Vice President of Quality

The Vice President of Global Quality Assurance is responsible for the strategic development and execution of the quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support GMP, GLP and GCP compliance in accordance with ICH, US and EU regulations. This position is responsible for establishing and maintaining strong relationships with external vendors and/or consultants, as required for continued support of QA activities and responsibilities for the global company. The Vice President of Global Quality Assurance provides analysis and advice in the areas of pharmaceutical quality and compliance matters and is overall responsible for product life cycle management.

This position requires Large Molecule experience. The ideal candidate would have late stage / approved product experience and also be able to span QA for GMP, but also clinical and QC. Direct experience with regulators is a bonus.

Responsibilities:

• Overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical functions. Determines applicable quality standards and regulations and provides guidance and quality oversight to ensure ongoing compliance.
• Ensures that the Quality System meets standards expected by US and global regulatory authorities for research, development and commercial activities. Establishes, maintains, and has oversight of internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and timelines.
• Develops Gap Analysis Assessments and Risk Analysis of vendors’ and distributor’s operations to ensure evaluation of key areas, such as manufacturing operations, laboratory, training, maintenance and engineering, are in compliance with all applicable regulatory requirements, e.g. cGMPs, FDA Guidelines, USP, ICH, etc.
• Provides advice to company and company vendors on regulatory and/or quality issues with particular emphasis on FDA issues. Maintains ongoing vendor qualification program.
• Advise or actively participates in the development of procedures, practices, and systems that ensure compliance with regulatory standards with particular emphasis on cGMP compliance.
• Serves as primary Quality contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.
• Serves as primary Quality contact and manages regulatory agency investigations and/or administrative actions brought against company and company’s vendors with particular emphasis on FDA or other global health authorities’ issues. Interacts with regulatory officials to convey to compliance level of various quality systems during regulatory inspections.
• Reviews and approves correspondence with regulatory authorities in conjunction with Regulatory Affairs.
• Performs due diligence audits and provides regulatory reviews and analyses of new business ventures or acquisitions.
• Supports new product launches.
• Monitors and tracks proposed FDA guidance documents, good manufacturing practice regulations, and other healthcare-related regulations that will impact businesses.
• Oversee all documentation supporting shipment of product manufactured prior to shipment and distribution.
• Manages and executes life cycle management program including Product Complaints, ADEs, Annual Reports and Management Review.
• Provide on-going oversight to the existing QMS and training program and implementation of new procedures and policies as necessary.
• Generates and maintains departmental budget in accordance with company’s business objectives.
• Manages Returned Goods process, Field Alerts and Product Recalls.
• Assist CMOs with FDA 483 and Warning Letter responses, as necessary.
• Keeps abreast of industry developments, forthcoming regulations, guidance, best practices etc.
• Counsels, trains and interprets quality requirements to ensure we and our GxP vendors maintain in a state of compliance.
• Conducts all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines.

Requirements / Qualifications:

• Bachelor’s degree in Science (Biology, Chemistry, etc.) or Life Science discipline required, Master’s degree preferred.
• Minimum of 15 years of relevant experience in GXP, Quality Assurance management or Quality Assurance leadership positions in a biotech or pharmaceutical industry required.
• Minimum of 7 years of experience managing a team required
• Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities
• Experience interacting with regulatory health authorities at pre- and post-approval inspections
• High ethical standards.
• Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management
• Detail oriented with a firm understanding of the issues and business focused strategies.
• Skilled in making risked based decisions from a regulatory and business perspective.
• National and international travel may be required as business needs arise.