Director of Quality Assurance, Pharmaceutical Manufacturing

Title: Director of Quality Assurance, Pharmaceutical Manufacturing

Location: Exton, PA

Reports to : James Huang, Global Vice President, Quality Assurance, and IT Compliance

Position type : Full-time.

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance and ensures seamless integration with global quality processes.

The Director of Quality Assurance, Pharmaceutical Manufacturing monitors manufacturing, packaging, releasing, disposition, testing and validation activities, performs product inspections, and verifies process and product documentation. The [Position Title] also identifies risks and deficiencies, conducts root cause analysis, and checks CAPA effectiveness.

Responsibilities:

• Manage the quality assurance department to support the GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production. The dosage forms include oral solid and liquid, semisolid, and sterile etc.
• Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• Host regulatory agent inspection such as FDA, EU QP, and DEA. Provide responses to ensure quality compliance.
• Develop and approve quality agreements with client, host client audit and provide responses, and ensure action items are completed to meet the requirements.
• Develop, implement, and oversee quality systems at Frontage manufacturing facility to ensure product reliability, quality, efficacy, and alignment with global standards.
• Develop, maintain, and continuously Review and approve quality documents such as SOP, change controls, OOS, Deviations, CAPAs, MV protocols, MV reports, batch records, COA, product release with the statement of GMP compliance.
• Manage supplier qualification including quality agreement, and audit report.
• Provide staff annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance.
• Maintain and continuously improve the use of electronic quality management system, ZenQMS.
• Other duties as assigned.

Education, Experience & Skills Required:

• BS or advanced degree in a scientific discipline or related area
• 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality
• 6-8 years of experience in quality management and leadership positions
• 5 years of experience in the quality for late phase clinical trial material and commercial drug manufacturing of various format such as solid, semisolid, sterile liquids etc.
• Demonstrate strong knowledge of US, EMA and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211)
• Experience in hosting regulatory authorities’ inspections and providing responses.
• Thorough understanding of GMP regulations and industry practices in terms of key quality performance indicators (KPI)
• Strong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls)
• Experience leading deviation and non-conforming material investigations.
• Demonstrated success in coaching, mentoring, and training across functions.
• Excellent written, oral, and interpersonal communication skills.
• Ability to think and act strategically.
• Self-directed, multi-tasker and ability to work effectively with cross-functional teams.
• Proven technical writing/editing skills and problem-solving ability.
• Strong attention to detail, excellent organization skills and cultural fit.
• Proficiency in Microsoft Office applications
• Ability to operate in a fast-paced, multi-disciplinary virtual environment.
• CDMO or CRO experience preferred.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.