SENIOR DIRECTOR, API QUALITY
Reporting to the Vice President, Quality and Compliance, this position will require regular interaction with senior management and executives on matters concerning the quality of products and contractor compliance. The incumbent is expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. He/She will be expected to exercise judgment within broadly defined regulations in selecting systems and evaluation criteria for obtaining results. He/She will ensure budgets, schedules, and performance requirements are met.
To establish and manage quality standards, systems and procedures to assure the quality and Good Manufacturing Practice (GMP) compliance of Principia’s active pharmaceutical ingredients (APIs). To provide quality oversight of API process development, validation and manufacturing activities.
Policies, Systems and Procedures
• Establish and maintain appropriate policies and procedures for the manufacture of Principia’s APIs.
• Lead, coach, facilitate, and support problem-solving, analysis of data and continuous improvement activities.
• Participation in contract manufacturer selection, commissioning, qualification and certification.
• Negotiation of quality agreements with contract manufacturers.
• Approval of development, transfer, master and study specific validation protocols and reports.
• Verification of process data and approval of technical protocols, reports, and chemistry, manufacturing and control sections of regulatory submissions.
• Approval of production related activities via approval of: specifications, master batch records, change controls, sampling and testing plans, stability study protocols and reports.
• Leading deviation and out of specification investigations.
• Review of executed batch records and releasing API batches, certifying compliance with regulatory commitments/filings.
• Conduct domestic and international audits of contract manufacturers, participating cross functionally with internal stakeholders to assure compliance with GMP regulations and Principia Standards Operating Procedures (SOPs).
• Conducting internal quality audits to assess Principia’s GMP compliance.
• Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop root cause Corrective and Preventive Action (CAPA) plans.
• Maintaining databases for audit observations and CAPAs.
• Tracking, reviewing, approving, and assessing the effectiveness of CAPAs.
Competent Authority Inspections:
• Facilitate and assist with the preparation, coordination, and management of Competent Authority inspections of Principia and contract manufacturers.
• Prepare contract manufacturers for Competent Authority GMP inspections, including pre-approval inspection.
The position requires a B./M.Sc./Ph.D. in chemistry, chemical engineering or equivalent; 15+ years of experience in pharmaceutical development with an ethical pharmaceutical company with 5+ years of experience managing technical professionals (with bachelor degrees); a thorough knowledge of scientific quality by design principles; current and strong working knowledge of US and EU GMPs; ICH-Q7 and quality guidelines; Part 11 requirements; and demonstrated success in quality oversight of late phase development and process validation. Candidates must demonstrate expert problem solving, organizational, planning, prioritizing, decision-making, as well as exceptional communication (written and oral), negotiation and influencing skills. Strong computer skills in applications used in a general office settings such as word processing, spreadsheets, presentations, data base management, and internet search engine applications is also required. This position may require up to 40% travel.