Director, Commercial Operational GMP Quality (Hybrid)

Job Description

General Summary:

The Director, Commercial Operations GMP Quality role for Biologics and Combination Device Quality will be responsible to strategize, plan, implement, execute, and maintain global Quality Operational organization, processes, and systems.in compliance with global Biologics and Medical Devices regulations, Guidance Documents, and standards. The role will have hand on experience in working cross-functionally and with external partners in establishing effective and compliant processes and systems to maintain continuous level of regulatory compliance and successful outcome from regulatory inspections. The role will be responsible for working with internal and external stakeholders in a matrix environment, Influencing/building/promoting a culture of Quality and to meet business, quality and regulatory objectives.

Key Duties and Responsibilities:

• Act as a Commercial Biologics and Device Subject Matter Expert (SME) for Vertex's Biologics and Combination Products.

• Create Commercial Quality Operational Strategy for Biologics Programs, leading, implementing, executing, and maintaining organizational, process, and systems infrastructure.

• Partners with internal Corporate Quality, Manufacturing, Supply Chain, Distribution Quality, and externally with Contract Manufacturing and Testing Labs for a successful, compliant, and effective commercial product launch, globally.

• Partner and lead regulatory pre-approval inspections and routing regulatory inspections to ensure successful outcome.

• Quality oversight of product, process, analytical validation, Technical Transfers, and CMC product development activities.

• Establishment Commercial Quality Agreements and maintain close oversight with external contract partners to ensure compliance with Quality Agreement and regulatory requirements.

• Responsible for commercial Biologics Device QA Product Disposition and Release, Change Control, Supplier Corrective Actions, Compliant Management, Quality Management Reviews, Annual Product Review, Recall Management, external partner oversight, and many other quality management systems,

• Identify and communicate risks and assist with risk mitigation plans as necessary

• Represent Biologics and Quality to lead/participate in complex project involving biologics and medical device and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

• Lead/participate with cross-functional stakeholders in Biologics and Device Team with projects and improvements, and associated mitigation plans to meet business, Quality and regulatory objectives.

• Provide necessary commercial quality support for global license application preparation.

• Development and coaching of Staff

Knowledge and Skills:

• Technical competency and knowledge on Biologics Drug Substance, Drug Products Fill and Finish, Analytical Testing, Process Validation, Analytical Test Validation and global biologics regulations and standards.

• Technical knowledge on sterility Assurance, Contamination Control, Microbiology

• Quality and Compliance Subject Matter Expert in Commercial Quality and Combination Devices

• Analysis, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

• Ability to apply risk management principles to decision making and operational priorities

• Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of Quality

• Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.

• Subject Matter Expert in leading and hosting successful regulatory inspections.

• Excellent track record in maintaining positive, proactive, and professional relationship and partnership with external partners.

Education and Experience:

• B.S. in Science (Chemistry, Biology, Microbiology)

• 15+ years of relevant work experience in commercial quality within Biologics including experience in launching biologics product, globally

#hybrid

Pay Range:

$176,000 - $264,000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base