The Executive Director, GxP QA Operations, is responsible for developing, managing all aspects of the Quality Operations functions for drug/device combination aseptic products through all phases of product development, clinical, commercial and life-cycle. This individual will manage through direct reports the following Quality functions (Quality Systems, Lot Release and Shop Floor Compliance, Device Engineering and Validation). This candidate will serve as the key Quality Technical Lead representing Quality during regulatory audits and the subject matter expert on various quality projects including liaising with regulatory agencies on quality and compliance related matters. The candidate will have direct responsibility for managing all Quality Operations in Hayward and support GCP activities in Boston (as needed).
Duties and Responsibilities:
Provide strategic leadership, development and implementation of GxP Quality Management Systems for drug/device combination aseptic products.
Develop and maintain a compliant Quality Management System to comply with applicable company, US and worldwide regulatory requirements including standards, guidance and procedures.
Oversee and manage all aspects of Quality Operations functions; Lot Release and Shop Floor Compliance, Quality Systems (Deviations, CAPA, Change Control, OOS, Product Complaints, Internal Audits and Risk Management and Failure Analysis), Device Engineering and Validation (facilities, equipment, processes and computer systems).
Support scheduling and preparing presentations on significant quality matters for the management review board i.e., MRB, QRB, etc.
Conduct periodic Product Quality and Management Review, including tracking, trending all KPIs (QA metrics and scorecard) and design effective action plans to address trends.
Identify, assess and communicate QA strategies, KPI metrics, gaps and compliance risks to senior management on a periodic basis.
Partner with Technical Operations (Manufacturing, MSAT, Supply Chain, Product Development, Regulatory Affairs, and other functions of the Quality Organization) to drive corporate objectives and ensure that the site operates and complies with all quality, regulatory and compliance requirements.
Act as the Team Lead for all QA and Compliance related activities in preparing the site for inspections (General, PAI) and commercial readiness preparations for both US and EU territories.
Serve as the QA Technical lead representing Quality during regulatory audits i.e., US FDA, EU, Notified Body for CE Mark, State Food and Drug including partner audits.
Provide guidance on regulatory standards for compliance with US and EU regulations for Sterile Products (combination products) including CE Mark Technical Files/Dossiers.
Support the Supplier Quality group to conduct audits and management of critical service providers and vendors.
Develop a high performing team to manage GxP Quality responsibilities. Hold the team accountable for preparing and achievable tactical goals.
Prepare accurate budget and headcount forecasts for Quality and Oversee the organization within allotted budget and headcount.
Provide training, development and growth opportunities for employees.
A minimum bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
Seasoned professional in GxP Quality Operations (QA and QC) for drug/device combination aseptic products preferably with direct leadership, management and oversight of manufacturing site.
Thorough understanding and knowledge of cGMP regulations (21CFR210, 211, 21CFR820, 21CFR4, EU Directives and Guidelines, EU Annex 1, 11, 15), ISO 13485, 11135, 11137, CE Marking and ICH guidance’s (i.e., Q7, Q9. Q10).
Strong understanding of GMP computer systems with compliance to Part 11 and EU Annex 11 requirements is desired.
Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.
A minimum experience of 20 years in the drug/device pharmaceutical and biopharmaceutical industry with multiple areas of functional and technical expertise. Proven track record with a strong knowledge of aseptic processing and managing commercial drug-device combination aseptic products is highly desirable.
A minimum of 10 years in senior management positions leading Quality Operations functions either in small and/or big pharma with attention to details.
Proven track record of successfully managing PAI for aseptic products.
Ability to work independently on technical and quality projects initiatives with minimum supervision.
Pro-active and identifying opportunities along with strong problem solving and negotiation skills.
Ability to work hands on in an entrepreneurial, fast paced environment. Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
Strong verbal, written communication skills and computer skills are required. Must be goal-oriented, quality-conscientious, and customer-focused.