Senior Pharmaceutical Quality Assurance Director

7 days ago

Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Overview

We are seeking a Senior Pharmaceutical Quality Assurance Director to join our team at Frontage Laboratories, an award-winning Contract Research Organization (CRO). This is a critical role in ensuring the development, maintenance, and continuous improvement of quality management systems.

About Us

Frontage Laboratories operates over 25 state-of-the-art laboratories across the US, Canada, and China. 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.

Job Summary

The Senior Pharmaceutical Quality Assurance Director will play a key role in upholding quality standards and compliance by monitoring manufacturing, packaging, releasing, disposition, testing, and validation activities. The successful candidate will also be responsible for hosting regulatory agent inspections and providing responses to ensure quality compliance.

Responsibilities
  • Manage the quality assurance department to support GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production.
  • Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
  • Host regulatory agent inspections such as FDA, EU QP, and DEA, and provide responses to ensure quality compliance.
  • Develop and approve quality agreements with clients, host client audits, and provide responses, ensuring action items are completed to meet requirements.
  • Develop, implement, and oversee quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
  • Develop, maintain, and continuously review and approve quality documents such as SOPs, 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, offering 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.
Requirements
  • Bachelor's 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 quality for late-phase clinical trial material and commercial drug manufacturing of various formats 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 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.
Salary and Benefits

Frontage Laboratories offers a competitive compensation and benefits package, including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. We strive to create a positive work environment that supports your personal and professional growth.

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