Doris Fomulu
North Hollywood,CA
Summary
Accomplished Executive Director recognized for leveraging strong team leadership and development to drive forward progress. Highly organized, detail-oriented leader skilled in directing high-performing teams to develop solutions and solve operational and technical problems. Success implementing systems across multiple operations with superior organizational and communication skills.
Overview
25
25
years of professional experience
Work History
Executive Director, Supplier Quality
Arcutis Biotherapeutics, Inc
03.2023 - Current
- In addition to responsibilities as Director, Supplier Quality, managed a diverse team of professionals, fostering a collaborative work environment for increased productivity in the oversight of development, clinical and commercial contract manufacturing organizations and contract laboratories for the production, testing, storage and distribution of topical drugs.
- Developed strategic partnerships with key stakeholders to expand the organization's reach and influence.
- Optimized operational workflows, reducing overhead costs and maximizing resource allocation.
- Guided staff through periods of organizational change, maintaining morale and engagement during transitions.
- Strengthened internal communication channels to facilitate cross-functional collaboration and decision making.
- Increased organizational efficiency by streamlining processes and implementing new systems.
Director, Supplier Quality
Arcutis Biotherapeutics, Inc
07.2021 - 02.2023
- Designed and implemented of Supplier Oversight QMS processes for supplier qualification (CMOs, CTLs, 3PLs, artwork suppliers, product complaint contractors, IT and serialization vendors), and product release to the US and Canada commercial markets.
- Spearheaded the role of Quality Assurance on the commercial launch team to ensure compliance with QMS and regulatory requirements in alignment with product launch timelines.
- Established a culture of continuous improvement by fostering open communication channels cross functionally.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Negotiated favorable contract terms with vendors for reduced costs and improved service quality.
Sr. Quality Specialist
Amgen Inc.
02.2009 - 07.2021
- Special Assignment (March 2020 – July 2021): Integrated Product Surveillance (IPS) – Co-led the redesign of the Complaint Handling Program integrating the Quality and Safety Organizations, improving record quality, data quality and compliance.
- Process Owner for various Quality Management System (QMS) Processes across multiple Amgen sites covering development, clinical and commercial operations. Processes included: Risk Management, Complaint Management, Audits and Inspections, Recalls, FARs & Market Withdrawals and Change Management, Accomplishments:
- Streamlined quality assurance processes for increased efficiency and reduced waste.
- Defined and implemented program deployment and improvement strategies in alignment with Amgen's operating paradigm.
- Defined meaningful metrics to drive systemic sustainable improvements.
- Developed comprehensive quality manuals outlining company policies, procedures, and expectations for all employees, ensuring consistent adherence to established guidelines.
- Conducted thorough risk assessments on new products or processes prior to implementation, minimizing potential adverse impacts on product quality or safety.
- Explaining/illustrating/defending program controls internally to users and externally to Amgen Partners and Regulatory Authorities
- Disseminating and driving assimilation of global requirements at the site level.
Manufacturing Quality Specialist, Cell Bank Manufacturing
Amgen Inc.
08.2006 - 02.2009
- Re-designed and maintained the cell bank long-term storage stability monitoring program for over 45 cell banks, ensuring compliance with ICH requirements.
- Developed strong cross-functional relationships through consistent communication and attentive service and represented the Cell Bank department on cross-functional product strategy teams.
- Led out-of-trend and out-of-specification investigations.
- Authored Cell Bank Chemistry Manufacturing Controls (CMC) sections for regulatory submissions.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
Manufacturing Associate III, Cell Bank Manufacturing
Amgen Inc.
10.2003 - 08.2006
- Improved production efficiency by streamlining manufacturing processes and implementing lean manufacturing records and techniques.
- Increased team productivity by providing ongoing training, guidance, and support to fellow associates.
- Responsible for ownership of cell bank QMS records: change management, deviation and CAPA records.
- GMP execution of cell banking operations for creation of master and working cell banks.
Training and Development Specialist, Formulation & Finishing
Baxter BioScience
04.2002 - 10.2003
- Managed multiple projects simultaneously while maintaining strict deadlines and adhering to budget constraints.
- Adding to the responsibilities of a Department Specialist: Enhanced employee performance by designing and implementing comprehensive training programs; defining core competency training requirements-based position and job descriptions and delivering training including new hire orientation and on-the-job training;
- Streamlined training processes by identifying areas of improvement and implementing targeted solutions.
- Collaborated on the development of the fill line: Creation of SOPs, Material Specifications, Cycle Development for the Fill line isolator and VHP Bio-decontamination system, execution of the validation qualification protocols (IOQ and PQ).
Department Specialist, Formulation & Finishing
Baxter BioScience
08.2000 - 04.2002
- Used critical and analytical thinking skills to conduct deviation investigations.
- Used technical writing skills to write investigation reports reports and change assessments.
- Executed material transfers for the Bulk Drug Substance (BDS) for Factor VIII production
- Batch record and general document review for lot release purposes.
- Performed inventory management activities assuring adequate supply of product components and materials, using the Material Requirements Planning (MRP) Application and JD Edwards Software and SAP.
- Supported filling operations and fill schedule planning.
Quality Control Specialist, Microbiology
Baxter BioScience
06.1999 - 08.2000
- Environmental Monitoring of viable and non-viable air and surfaces in clean rooms and clean zones.
- Personnel monitoring for sterility and aseptic filling operations.
- Bacterial identification.
- Growth promotion and contamination check assays.
- Bioburden testing of Water-For-Injection, Reverse Osmosis, City Water, Clean Steam and Compressed Gas systems
- Equipment validation.
Education
Masters in Regulatory Science Program - Ongoing -
University of Southern California
Los Angeles, CABachelor of Science Degree - Biology and Chemistry -
Delaware State University
Dover, DE06.1999
Skills
- Operations and Quality Management
- Contract Management and Vendor Relations
- Leadership Development
- Risk Management
- Change Management
- Regulatory Compliance
- Training and Development
- Program Leadership
Accomplishments
- Developed and managed a Quality Assurance team leading them through 3 successful product launches in 2 years ahead ot time and under budget at Arcutis.
- Designed, implemented and improved upon QMS processes at Arcutis and Amgen
- Designed and implemented Inspection management programs at Arcutis and Amgen leading to over 40 regulatory inspections and partner audits with successful outcomes
- Developed, coached and mentored high performing teams
Timeline
Executive Director, Supplier Quality
Arcutis Biotherapeutics, Inc
03.2023 - Current
Director, Supplier Quality
Arcutis Biotherapeutics, Inc
07.2021 - 02.2023
Sr. Quality Specialist
Amgen Inc.
02.2009 - 07.2021
Manufacturing Quality Specialist, Cell Bank Manufacturing
Amgen Inc.
08.2006 - 02.2009
Manufacturing Associate III, Cell Bank Manufacturing
Amgen Inc.
10.2003 - 08.2006
Training and Development Specialist, Formulation & Finishing
Baxter BioScience
04.2002 - 10.2003
Department Specialist, Formulation & Finishing
Baxter BioScience
08.2000 - 04.2002
Quality Control Specialist, Microbiology
Baxter BioScience
06.1999 - 08.2000
Masters in Regulatory Science Program - Ongoing -
University of Southern California
Bachelor of Science Degree - Biology and Chemistry -
Delaware State University
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