The Director of GMP Quality Operations will be the trailblazer of the company’s GMP Quality Operations via Quality Assurance (QA) and Quality Control (QC) oversight of the Supply Chain, from clinical development stages through global commercialization. Responsibilities include ensuring the effectiveness and compliance of the company’s key quality programs pertaining to vendor quality management and product quality, developing and issuing governing documents to ensure external and internal GMP compliance, as well as inspiring and promoting quality awareness and continuous improvement within the organization. This role will report to the CMO, and involve ongoing interaction with internal project team members as well as with external vendors, partners and supplier project teams.
- Establish the strategic quality assurance vision for the organization and provide the operational leadership to execute that vision in alignment with company’s goals.
- Lead and manage company’s GMP Quality Operations, specifically QA and QC activities pertaining to manufacturing and testing activities intended to support clinical and commercial drug products
- Establish and manage the GXP Quality Management System to ensure compliance with applicable GXP guidelines and Regulatory Agency requirements
- Work with core cross functional teams to support and establish key SOPs
- Support company’s compliance and inspection readiness program.
- Support interactions with and responses to Regulatory Agencies on GXP matters, including regulatory inspection support
- Drive activities pertaining to manufacturing (batch record review, stability, investigations, deviations) and other quality systems as intended to support product quality and the supply chain.
- Implement and monitor operational quality objectives for all stages of clinical development, through product launch and global commercialization.
- Serve as the quality operational lead on internal projects and external supplier teams.
- Establish and monitor appropriate metrics to track operational quality and process improvement; provide advice, education, expertise and assistance on quality related matters.
- Lead internal and external audits to satisfy regulatory GXP requirements and continuous improvement efforts.
- Establish and maintain effective working relationships with internal and external stakeholders.
- Travel may be required domestically and internationally (15-20%)
Skills and Attributes:
- Thorough knowledge of Quality Assurance (GLP, GMP, GDP, GDocP) to assure subject/patient safety, data integrity, product quality (SISPQ) and operational compliance.
- Successful track record managing quality operations while forming and maintaining strong internal and external business relationships.
- Strong organizational, decision-making and time management skills to drive quality operational decisions.
- Experience with the preparation and/or review of regulatory filing submissions (IND/IMPD/NDA).
- Ability to work effectively in a small fast paced startup company and prior experience in establishing QMS systems
- GMP vendor audits, agency/partner inspection conduct and audit management.
- Team oriented, supportive, and collaborative with a pro-active approach.
- Ability to lead and influence cross-functionally across organizations and with external partners and vendors.
- Strong verbal and written communication skills.
- Ability to handle multiple projects and appropriately resource for ongoing success.
- Desire to learn and develop professionally while helping to shape the compliance culture in the company.
Education and Experience:
- Bachelor’s degree in life sciences or chemistry, with approximately 10+ years GXP Quality Operational experience in a Pharmaceutical/Biotechnology setting with experience in any combination of GMP Operations, Quality Control, and Quality Systems.
- Effective experience building and leading GMP Operations for product Sponsors, CMOs and/or CROs.
- Mentoring and empowering junior staff, colleagues and collaborators.