Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Payal Patel

Summary

Dynamic quality management professional recognized for shaping and optimizing quality systems across pharmaceutical and biotechnology sectors. Proven track record in leading initiatives that align regulatory requirements with operational goals, resulting in enhanced process efficiency and team collaboration.

Overview

24
24
years of professional experience

Work History

Director, QMS Operational Controls Business Partner

Bristol-Myers Squibb (BMS)
New Brunswick, USA
11.2025 - Current
  • Collaborated on developing, modifying, and understanding user needs to meet regulatory requirements for the Operational Controls pillar of the BMS QMS.
  • Partner with stakeholders above site and at the site level to ensure they maintain document management capabilities, pull through global QMS requirements into their local documentation, and actively participate in QMS changes that will directly impact their operations.
  • Become a SME who understands the nuances needed for differentiation between regions in relation to execution of the process framework and the BMS QMS.
  • Engaged Process Owner Network, Global Stakeholders, and sites to drive process development and improvements.
  • Developed capability for effective information flow between Global and Local teams.
  • Established communication channels to align upstream and downstream L2 process impacts.
  • Maintain Network Health by ensuring GPO’s and GPL’s are in place and aligned to the ongoing GQ strategy.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.

Director, Quality Management Systems

Bristol-Myers Squibb (BMS)
New Brunswick, USA
06.2024 - 11.2025
  • Provide strategic and tactical direction for multiple QMS processes. This includes developing a multi-year roadmap to both capture quantified value opportunities and mature the QMS.
  • Led regulatory surveillance and benchmarking initiatives with internal and external peers to monitor regulatory changes and identify innovative practices and technologies.
  • Collaborate with both internal and external SMEs to identify and implement best practices to ensure optimal execution of processes.
  • Actively engage with leadership from business case development through project delivery, and ensure organizational alignment on scope, schedule, quality, benefits.
  • Ensure process health and optimization metrics are developed and monitored for associated processes, escalating issues to appropriate leadership teams for action and remediation.
  • Identify capability needs for maturity across assigned L2s and develop plan in partnership with the Director, QMS Operations to strengthen those capabilities across the L2s.
  • Defined and ensured effective interdependencies among processes and systems.
  • Directed decision-making for the L2 processes within my responsibilities.

Associate Director, GMQ Quality & Compliance Excellence, Global Manufacturing Quality

Bristol-Myers Squibb (BMS)
New Brunswick, USA
06.2022 - 06.2024
  • Led the development, direction, implementation, and maintenance of standardization, optimization, and continuous improvement of quality systems across the network.
  • Led initiatives for continuous improvement of the Product Disposition process and strengthened network maturity in delivering the QMS.
  • Identified and implemented continuous improvement opportunities for quality services processes, enhancing overall effectiveness.
  • Function as the Global Process Owner for the Product Disposition systems and all associated processes and procedures.
  • Represent Product Disposition as subject matter expert and process owner in a front-room capacity during all internal and third-party audits/inspections.
  • Performed periodic reviews and incorporated ongoing updates to regulatory requirements in Global BMS documents using a risk-based approach.
  • Serve as the Business Process Owner of CAPRI (Compliance and Product Release Innovation) Quality Applications for business process.
  • Planned and implemented lifecycle changes and system enhancements in collaboration with IT, streamlining operations.
  • Functioned as Business Owner of BPR (Batch Print Record) and Controlled Copy workstream in BMSdocs (Veeva vault), facilitating cross-functional collaboration to implement a harmonized BPR process.

Quality System Senior Manager, Global External Manufacturing

Bristol-Myers Squibb (BMS)
New Brunswick, USA
04.2021 - 06.2022
  • Responsible for leading regional teams within the Quality Systems and Network Support group in External Manufacturing. Responsible for ensuring the effective implementation of Quality Systems and Training within the Global External Manufacturing organization.
  • Developed direct reports through coaching, mentoring, training, and creating development opportunities that aligned with organizational goals.
  • Managed all aspects of the process, including procedures, training materials, and share point content.
  • Displaying technical knowledge of the process and understanding risks/weaknesses in the system.
  • Ensured compliance of process elements with regulatory requirements, health authority expectations, and BMS policies.
  • Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process.
  • Reviewed process metrics, trends, observations, and waste elimination regularly, providing actionable feedback to Quality management team for remediation and enhancement.
  • Owning relevant process issues – speaking to trends/issues/exceptions at ExM Tier 3 Quality Councils.
  • Acting as the subject matter expert in audits / inspections.
  • Developing and implementing pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance.
  • Responsible for ensuring appropriate support is provided by Quality Services regional teams to ExM Operations from a Quality Systems and Training perspective on a day-to-day basis.
  • Lead self-inspection audits.
  • Review regulatory inspection observations from other BMS sites for site compliance.
  • Identified and implemented continuous improvement opportunities within Quality Services processes, enhancing compliance and operational effectiveness.
  • Represented the Associate Director of Quality Systems in decision-making processes and communications.

Sr. Manager, Global Quality System, Deviation and CAPA

Bristol-Myers Squibb (Legacy Celgene Corporation)
Summit, USA
06.2019 - 04.2021
  • Function as the Quality System Owner for the CAPA and Deviation systems and all associated processes and procedures.
  • Author and maintain all standards, policies, procedures, work practices and job aides that support the CAPA and Deviation system ensuring all documents and processes comply with applicable regulations, guidance documents and industry best practices.
  • Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
  • Provide input to and execute the strategic roadmap for the electronic CAPA and Deviation modules in eQRMS.
  • Represented CAPA & Deviation as the subject matter expert and process owner during internal and third-party audits/inspections.
  • Created and distributed metrics, analytics, and performance indicators for CAPA and Deviation to enhance decision-making.
  • Collaborate with cross-functional system partners and represent the CAPA and Deviation user community in all governance and life-cycle related capacities.
  • Developed and executed a structured document hierarchy plan for CAPA and Deviation to enhance accessibility and ensure compliance with local and global standards.

Manager, Quality Assurance/Supervisor, Quality Assurance/ Sr. Compliance Specialist

Tris Pharma Inc.
Monmouth Junction, USA
02.2015 - 06.2019
  • Oversaw disposition of commercial and clinical products, ensuring compliance with company and regulatory requirements.
  • Prepare, review and approve APRs and associated sub reports for internal and external products.
  • Oversee investigation, CAPA and PDR functions.
  • Lead and/or assist during regulatory or customer audit/inspections (cGMP, PAI, Pharmacovigilance inspection).
  • Developed and analyzed business metrics; reported monthly metrics on investigation, CAPA, PDR, and APRs to quality leadership and relevant personnel.
  • Managed compliance activities related to GDP, RFT, and GCP projects.
  • Experienced in handling FAR & Recalls and communication with FDA district office.
  • Resolved production and documentation discrepancies in a timely and accurate manner.
  • Participated in product risk assessments to identify potential safety issues.
  • Manages, coaches, mentors and develops direct reports.

Supervisor, Quality Assurance

Tris Pharma Inc.
Monmouth Junction, USA
09.2016 - 03.2017
  • Managed the Tris Pharma CAPA, Deviation, Product Complaint system to ensure compliance with regulations and corporate guidelines.
  • Leveraged expertise in CAPA, Deviation, Product Complaint system to support plant compliance and resolution of CAPA issues.
  • Delivered training on CAPA process, improving compliance and promoting operational efficiency.
  • Supervised internal investigations and identified potential organizational risks to strengthen operational integrity.
  • Provided expertise in the Internal Audit system, Customer Audit, and Regulatory Inspection.
  • Ensured accurate transfer of information from initial and follow-up source documents for adverse event reports and managed case reports to regulatory timelines.
  • Assisted during regulatory or customer audit/inspections.
  • Manages, coaches, mentors and develops direct reports.

Sr. Compliance Specialist

Tris Pharma Inc.
Monmouth Junction, USA
02.2015 - 09.2016
  • Generated, reviewed, and approved internal investigations and customer complaints, enhancing compliance and quality assurance.
  • Executed investigations, root cause analysis, and CAPA activities, ensuring adherence to the company's Quality System.
  • Facilitated weekly meetings for open investigations, CAPA, planned deviations, and product complaints, promoting timely resolution.
  • Monitored and reported on essential metrics to ensure compliance.
  • Revised SOPs for Quality and managed related inspections.
  • Assisted with Annual Product review sub-reports.

Manufacturing Compliance Associate

Gallus Biopharma / Patheon Biologics
Princeton, USA
09.2014 - 01.2015
  • Identified, initiated, coordinated, and authored investigations, corrective and preventive actions, SOPs, and batch records to enhance compliance and operational integrity.
  • Perform review of Production batch records, logbooks, and other documentation to ensure accuracy, GMP compliance, identify potential investigations and perform final review and approval of batch records.
  • Ensure all documentation is completed to meet all disposition and project timelines. Track and perform trend analysis related to investigations and corrective actions (CAPA’s)in Trackwise.
  • Identify, analyze, and communicate trends and perform root cause analysis.
  • Participate, lead, and/or coordinate meetings related to investigations or projects and represent the Manufacturing organization and serve as liaison with QA and other departments on site.
  • Led site Change Control process for Manufacturing department; facilitated document concurrence and championed SOP and batch record revisions while maintaining training on job responsibilities.

Investigations Writer

G & W Laboratories Inc
South Plainfield, USA
01.2012 - 09.2014
  • Actively participate in conducting & writing manufacturing/operation investigations for product failures using standard industry investigation.
  • Ensure that Investigation Reports accurately identify all processing and manufacturing deficiencies to determine and classify root cause.
  • Identified and documented process deviations, change controls, and corrective actions (CAPAs) in Trackwise to enhance compliance.
  • Executed corrective actions and implemented innovative process improvements to address identified deficiencies.
  • Track, trend and evaluate manufacturing discrepancies and work to eliminate root causes.
  • Assess the impact of discrepancies on products or processes and recommend product disposition.
  • Initiated and resolved investigations within the allotted time frame per applicable SOP.

Cell Processing Associate

Dendreon Corporation
Morris Plains, USA
01.2010 - 01.2012
  • Aseptic GMP manufacturing of clinical and commercial human blood therapeutics in a clean-room environment with biological safety cabinets. Clean rooms are considered class ISO 5 or class 100.
  • Subject Matter Expert; leading, mentoring and training other associates in clean room behavior, aseptic process techniques GMP documentation, quality systems and safety.
  • Maintained standard operating procedures (SOPs), batch records and other applicable documentation to comply with regulatory requirements and good manufacturing practices (GMPs).
  • Performed manufacturing processes in a fast-paced high volume production environment maintaining high quality regulatory standards.
  • Supported supervisors and QA associates in identifying and documenting process deviations, change controls, and corrective actions (CAPAs), enhancing compliance and operational integrity.
  • Collaborated with department in cross-functional teams, projects and GMP-related troubleshooting and problem resolution.
  • Implemented corrective actions and innovative process improvements, driving enhancements in production reliability and quality.
  • Contributed to writing manufacturing investigations for product failures using standard industry investigation tools (e.g., Root Cause Analysis, DMAIC, 5 Whys), promoting accountability and continuous improvement.

Research Assistant / Bio-1 Life Science Research Fellow

3D Biotek
North Brunswick, USA
08.2009 - 01.2010
  • Performed Neutral Red, Alamar Blue and MTT assays on cells cultured in 2D and 3D and using chemotherapeutic drugs, performed cytotoxicity assays (MTT, LDH) with MCF-7 and HepG2 cells cultured in 2D and 3D.
  • Maintained sterile 2D and 3D cultures of stem cells, primary keratinocytes, cancer cell lines (MCF-7, HepG2), NIH-3T3 cells, and 7F2 osteoblasts to support various research projects.
  • Evaluated cell growth and function using novel 3D cell culture inserts.
  • Conducted Neutral Red, Alamar Blue, and MTT assays on 2D and 3D cell cultures with chemotherapeutic drugs, assessing cytotoxicity of MCF-7 and HepG2 cells.
  • Executed comparative studies of 3D Biotek’s 3D inserts against Matrigel, Basement Membrane Extract, and Collagen IV, utilizing NIH-3T3 and MCF-7 cells to evaluate efficacy.

Medical Assistant & Administrative Assistant

Healthmed Associates
Piscataway, USA
01.2006 - 12.2009
  • Conducted history evaluations, measured vital signs, and performed phlebotomy to facilitate comprehensive patient assessments.
  • Assisted with diagnostic and therapeutic procedures and examinations to support patient care.
  • Managed medical billing, coding, and insurance claims to ensure accurate reimbursement.
  • Ensured front desk was staffed for customer support.

QC Associates

Accumed
Lawrenceville, USA
07.2002 - 12.2002
  • Managed daily production of Listerine strips to ensure quality and consistency.
  • Applied GMP practices across laboratory assignments to maintain compliance and safety standards.
  • Conducted routine testing and troubleshooting to support product reliability and performance.

Education

Bachelor of Science - General Biotechnology, Biochemistry and Biological Science

Rutgers, The State University of New Jersey
New Brunswick, New Jersey
01-2010

Chemistry -

Middlesex County College
Edison, New Jersey
01-2008

Skills

  • Quality management
  • Regulatory compliance
  • Quality management systems
  • Document control
  • Process optimization
  • Risk management
  • Risk assessment
  • Continuous improvement
  • Data analysis
  • Project management
  • Project tools
  • Stakeholder engagement
  • Performance metrics
  • Root cause analysis
  • Problem-solving workshops
  • Strategic planning
  • Team leadership
  • Leadership development
  • Performance management
  • Team collaboration
  • Effective communication
  • Critical thinking
  • Decision-making
  • Staff development
  • Relationship building
  • Industry knowledge
  • Time management
  • Microsoft Office Suite

References

Available Upon Request

Timeline

Director, QMS Operational Controls Business Partner

Bristol-Myers Squibb (BMS)
11.2025 - Current

Director, Quality Management Systems

Bristol-Myers Squibb (BMS)
06.2024 - 11.2025

Associate Director, GMQ Quality & Compliance Excellence, Global Manufacturing Quality

Bristol-Myers Squibb (BMS)
06.2022 - 06.2024

Quality System Senior Manager, Global External Manufacturing

Bristol-Myers Squibb (BMS)
04.2021 - 06.2022

Sr. Manager, Global Quality System, Deviation and CAPA

Bristol-Myers Squibb (Legacy Celgene Corporation)
06.2019 - 04.2021

Supervisor, Quality Assurance

Tris Pharma Inc.
09.2016 - 03.2017

Manager, Quality Assurance/Supervisor, Quality Assurance/ Sr. Compliance Specialist

Tris Pharma Inc.
02.2015 - 06.2019

Sr. Compliance Specialist

Tris Pharma Inc.
02.2015 - 09.2016

Manufacturing Compliance Associate

Gallus Biopharma / Patheon Biologics
09.2014 - 01.2015

Investigations Writer

G & W Laboratories Inc
01.2012 - 09.2014

Cell Processing Associate

Dendreon Corporation
01.2010 - 01.2012

Research Assistant / Bio-1 Life Science Research Fellow

3D Biotek
08.2009 - 01.2010

Medical Assistant & Administrative Assistant

Healthmed Associates
01.2006 - 12.2009

QC Associates

Accumed
07.2002 - 12.2002

Bachelor of Science - General Biotechnology, Biochemistry and Biological Science

Rutgers, The State University of New Jersey

Chemistry -

Middlesex County College
Payal Patel