Dario Pedulla
Discovery Bay,USA
Summary
Senior Quality and Regulatory Affairs professional with 20+ years of experience in global quality management and regulatory compliance. Expertise in leading quality initiatives and cultivating excellence in multinational settings. Skilled in driving continuous improvement and managing complex quality systems to surpass compliance standards. Committed to upholding high standards in medical device and healthcare product sectors.
Overview
24
24
years of professional experience
Work History
Quality and Regulatory Affairs Senior Director
THERMOFISHER SCIENTIFIC
04.2017 - Current
- The Quality and Regulatory Affairs Senior Director is responsible for providing strong leadership to the quality organization, as well as be a member of the business leadership team. The quality function is responsible for the maintenance and development of a multi departmental quality system that complies with ISO 9001, ISO 13485, as well as FDA QSR and associated requirements. This individual serves as the Management Representative and primary contact with ISO 9001/13485 registrars, as well as FDA and other regulatory agencies.
- Fosters a quality culture to achieve site-wide program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus.
- Manages multiple departments responsible for quality systems, product quality, regulatory affairs and document control.
- Oversees the quality management system to ensure it is suitable, adequate and effective to support all applicable FDA Quality System Regulations, ISO 9001, ISO 13485, and the IVD Directive.
- Responsible for effective internal audit program, management reviews, operation procedure development, continuous improvement of the QMS and training of personnel on the quality system processes.
- Coordinates external audits for ISO registration, as well as FDA inspections; coordinate responses to customers’ supplier questionnaires.
- Responsible for the CAPA and complaint handling systems, and maintains quality metrics related to product/process quality and customer allegiance.
- Responsible for medical device regulatory affairs function and activities, including device, labeling and promotional reviews, regulatory submissions, and complaint reviews. Manages and maintains relationships with global partners to achieve international medical device registrations.
- Responsible for product compliance including electrical and mechanical safety, EMC, RoHS/REACH compliance, transportation safety and dangerous goods assessment.
- Drives consistent adoption of Quality Tools across the division, including 8D Corrective Action, Error Proofing, Failure Modes and Effects Analysis (FMEA), Design for Manufacturability (DFM), Statistical Process Control (SPC), Design Validation and Process Validation testing (DVT/PVT), and Critical to Quality (CTQ) documentation.
- Impacts product quality and compliance for assigned products, working with Operations, R&D and Product Support teams affecting warranty costs, instrument installations, and customer allegiance. Failure to perform could result in loss of ISO 9001 and/or ISO 13485 registration or FDA warning letters.
- Determines priorities for projects regarding maintenance and improvement of site-specific systems; recommends priorities and actions for those controlled by outside resources (such as division or corporate IT systems) affecting the local quality system.
- Has the necessary independence and authority within the organization, and through reporting relationships to initiate actions as needed to ensure the safety and efficacy of the medical products.
- Other miscellaneous duties as assigned.
Regulatory Affairs and Quality Manager - ANZ
THERMOFISHER SCIENTIFIC
02.2014 - 04.2017
- Devise, implement and execute effective regulatory and quality system strategies and processes for Thermo Fisher Scientific ANZ with the goal of exceeding compliance, minimising risk and maximising commercial opportunities.
- Ensure the appropriate certification, permits, licenses and registration compliance of the Company’s medical, scientific and environmental products and services.
- Assess, co-ordinate, prepare and submit regulatory submissions to meet Thermo Fisher Scientific business objectives across a multi business unit, diverse product portfolio. Provide updates to the senior leadership team and key stake holders across the ANZ organisation.
- Assess, review, update and proactively manage business priorities and regulatory workflow for Thermo Fisher Scientific ANZ including new product introductions, compliance audits, registration renewals and submissions.
- Effectively manage communications with all Australian and international regulatory authorities (E.g. TGA) to an appropriate standard, level of priority and timeframe.
- Provide expert advice across the Thermo Fisher Scientific ANZ organisation, for all matters pertaining to regulatory compliance and quality. Maintain awareness of developments in regulatory, legal, national and international standards that impact or potentially impact the organisation and products.
- Review and approve product labelling and marketing communications for regulatory and product claim compliance.
- Ensure accountability and follow through of corrective actions/recalls including communications with appropriate regulatory agencies.
- Lead improvement initiatives across the business that will enhance organisational compliance and improve employee awareness around the quality and regulatory function.
- Proactively partner with key business stakeholders to understand key business matters and any areas of impact from a regulatory and quality perspective.
- Appointed Site Leader for New South Wales within 3 months of permanent position
Head of Global Quality Management Systems
OUTOTEC
01.2013 - 11.2013
- Responsible for quality performance globally and within the SEAP region.
- Through International management and virtual team management via phone, VC and monthly meetings thus ensuring that still able to influence people throughout my area of responsibility.
- Required to be able to take hands on understanding and approach which allowed me to be able to lead as well as take charge when busy or required.
- Form part of the global quality management forum.
- Supporting the development of business processes and systems from a quality perspective globally by working with international areas of the company to maintain applicable standards.
- Development, Integration and Implementation of global processes and procedures relating to quality.
- Definition of quality competencies.
- Preparation of monthly and annual quality reports, with reference to and evaluation of the current quality status as well as determination of the appropriate improvement and correction requirements.
- Development of performance metrics (KPI’s) for quality systems.
- Management and maintenance of relevant external quality accreditations and compliance with legislation.
- Communication of all new standards or regulations relevant to Outotec’s operations, including updates to existing standards or regulations.
- Responsible for quality performance, including QC, QA administration.
- Supporting the development of business processes and systems from a quality perspective.
- Initiate, coordinate, document and monitor the activities of the corrective and preventative actions and review of non-conformances related to Quality.
- Management of internal and external staff members, supervisors, inspectors performing quality functions for Outotec.
- Development, Integration and Implementation of global processes and procedures relating to quality.
- Globally certified in all three major ISO standards 9001, 14001 and OHSAS 18001
General Manager – Australia
PHARMAPAK TECHNOLOGIES
05.2010 - 12.2012
- Provide leadership and vision to the organization by assisting the owner and staff with the development of long range and annual plans, and with the evaluation and reporting of progress on plans.
- Oversee preparation of an Annual Report summarizing progress on short and long range plans.
- Coach, facilitate and mentor departments in technical and leadership skills.
- Implementation and introduction of SAP throughout the whole facility
Quality Assurance Manager (Consumer Health Nationally)
PERRIGO AUSTRALIA
, Australia
04.2005 - 03.2010
- Co-ordination and administration of the QC and QA functions for all current global manufacturers within APAC and Europe.
- Required to be able to take hands on understanding and approach which allowed me to be able to lead as well as take charge when busy or required.
- Responsible for batch release, release approvals of raw materials & finished products from contract manufacturers.
- Auditing of contract manufacturer’s internationally to the applicable GMP’s and FSANZ.
- Determine the disposition of all finished products.
- Effect and efficient system of review of cGMP/FSANZ practices via the external audit program, such that all regulatory requirements are satisfied.
- Co-ordinate cGMP / ISO / FSANZ training for new personnel, contractors and staff.
- Control and maintain a documentation system to ensure all SOPs and testing specifications remain current and accurate.
- Development of new Drugs and Poisons Control Procedure for scheduled products within New South Wales.
Associate Director Process Excellence and Quality Management
JOHNSON & JOHNSON
, Belgium
07.2001 - 02.2005
- Provide leadership and support on process and product issues.
- Propose and implement improvement projects that improve compliance, efficiencies, yields or throughputs.
- Design and perform process development experimentation.
- Develop and review R&D and laboratory process documentation.
- Develop the necessary equipment, process and product knowledge to be recognised as a local experts.
- Lead or support process development and improvement activities.
- Support and / or develop and execute equipment or process related validations in accordance with requirements, processes and procedures.
- Define root cause and implement solutions to equipment and process related non-conformances utilizing the CAPA processes.
- Coach, facilitate and mentor departments in technical and leadership skills.
Education
Ph.D. - Biochemistry
Rutgers University
New Brunswick, NJ06-2002
Master of Science - Laboratory Quality Analysis And Management
Macquarie University
Sydney NSW Australia12-1999
Associate Diploma - Inorganic Chemistry, Organic Chemistry, Biochemistry, Calculus, Statistics
ADVANCED MATERIAL & TECHNOLOGY UNIVERSITY
Western Australia01.1995
Advanced Certificate - Chemistry, Physics, Geology, Biology, Statistics, Basic Electronics
ADVANCED MATERIAL & TECHNOLOGY UNIVERSITY
Western Australia01.1992
Leaving Certificate - Mathematics, Geography, Physics, Chemistry, Computing, Human Biology
KEARNAN HIGH SCHOOL
01.1989
Skills
- Quality systems management
- Regulatory compliance
- ISO 9001 and 13485 standards
- Audit management
- Continuous improvement strategies
- Material release expertise
- Quality system maintenance
- Remote QA team leadership
- Statistical analysis and reporting
- Knowledge of TGA, FDA, EU regulations
- Business process mapping
- Strategic influencing abilities
- Communication and reporting skills
- Corrective and preventative actions implementation
- Data management and trend analysis
Accomplishments
- Advanced Material & Technology University, Western Australia
- Kearnan High School, 1985 - 1989, Leaving Certificate, Mathematics, Geography, Physics, Chemistry, Computing, Human Biology
Academic Societies
IVD Australia – TARSC Committee Member
Further Training
- Presentation Skills Workshop
- International Quality Control Concepts and GMP
- Negotiation Skills
- International QA/QC Manager Training
- Managerial Training
- HACCP in Practice
- Practical Aspects of Pharmaceutical Validation Quality System Training (Certified)
- ISO 9000 Series Lead Auditor Training (Certified)
- GMP/Quality Systems Requirements and Industry Practise
- ISO 17025 Auditors Training
Dependants
None
Languages
- English, first language
- Italian, Proficient
Awards
- Best Practise for GMP Validation
- Standards of Leadership Award – Johnson & Johnson for work carried out on the Cypher Project
References
Available on request
Goals
- To contribute to and be successful within my chosen industry
- To be fairly challenged and financially secure
- To maintain a balance between work, leisure and family life
Personal Information
- Health Status: Excellent
- Date of Birth: 02/27/72
- Nationality: Australian, Green Card USA
- Marital Status: Married
Timeline
Quality and Regulatory Affairs Senior Director
THERMOFISHER SCIENTIFIC
04.2017 - Current
Regulatory Affairs and Quality Manager - ANZ
THERMOFISHER SCIENTIFIC
02.2014 - 04.2017
Head of Global Quality Management Systems
OUTOTEC
01.2013 - 11.2013
General Manager – Australia
PHARMAPAK TECHNOLOGIES
05.2010 - 12.2012
Quality Assurance Manager (Consumer Health Nationally)
PERRIGO AUSTRALIA
04.2005 - 03.2010
Associate Director Process Excellence and Quality Management
JOHNSON & JOHNSON
07.2001 - 02.2005
Ph.D. - Biochemistry
Rutgers University
Master of Science - Laboratory Quality Analysis And Management
Macquarie University
Associate Diploma - Inorganic Chemistry, Organic Chemistry, Biochemistry, Calculus, Statistics
ADVANCED MATERIAL & TECHNOLOGY UNIVERSITY
Advanced Certificate - Chemistry, Physics, Geology, Biology, Statistics, Basic Electronics
ADVANCED MATERIAL & TECHNOLOGY UNIVERSITY
Leaving Certificate - Mathematics, Geography, Physics, Chemistry, Computing, Human Biology
KEARNAN HIGH SCHOOL
Similar Profiles
Christine GlodyChristine Glody
Inventory Analyst II at Cole-Parmer (Division of Antylia Scientific formerly ThermoFisher Scientific)Inventory Analyst II at Cole-Parmer (Division of Antylia Scientific formerly ThermoFisher Scientific)
KATHERINE REMERKATHERINE REMER
Customer Service Representative at Thermofisher ScientificCustomer Service Representative at Thermofisher Scientific
RIYA ANN SAMUELRIYA ANN SAMUEL
Downstream Specialist at Thermofisher ScientificDownstream Specialist at Thermofisher Scientific
Christopher MetzenChristopher Metzen
Operator Technician - Biotechnology at Thermofisher ScientificOperator Technician - Biotechnology at Thermofisher Scientific
David DelimaDavid Delima
Outside Sales Representative at Lions FlooringOutside Sales Representative at Lions Flooring