Director QA/GMP Lab

Director of QA, GMP Lab

Title: Director, GMP QA

Location: Exton PA

Reports to: VP, BGC Therapy

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 will be responsible for daily GMP operations and managing Lab quality system. Reporting to the Senior Director Quality Assurance GMP, this individual will be responsible for building and maintaining a fit-for-purpose GMP quality system for Biologics, Gene, and Cell Therapy (BGC) Operations team. The Director will provide strategic oversight and leadership to QA Client liaisons to ensure quality objectives are attained for Client’s projects.

Roles & Responsibilities:

• Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented.
• Supports the reconciliation of GMP documentation.
• Approves reports, investigations, and other Quality System records on behalf of QA.
• Work cross-functionally with Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues and provide solutions with regards to issues impacting the release testing and stability programs.
• Develop and implement procedures, programs, and policies to support GMP operations and improve efficiency, ensure targets and business goals are met, and support a Right-First -Time approach.
• Provides support for both internal and external (client and regulatory) inspections. Manage regulatory inspections and other per-inspection readiness audits.
• Support the development of quality systems, deploy them into BGC organization, and ensure laboratory conform to defined requirements and standards.
• Understand and deploy processes to assure conformance to regulations. 
• Responsible for adherence to specifications and procedures that have been established to ensure testing quality.
• Support review of the suitability and effectiveness of the quality system with senior management.
• Manage overall cGMP training for continuous and onboarding new employees.

Education, Experience & Skills Required:

• Bachelor’s degree in science or related field required, 10 years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.
• Must have experience working in cross-functional teams including, CMC, analytical, QC, and external Clients.
• Experience managing and conducting external audits of laboratories.
• Experience managing document/SOP, change controls, deviations, product complaints, annual product reviews.
• Must be able to articulate complex issues clearly verbally and written.
• Experience in data collection and metrics.
• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance.
• Ability to self-direct and adapt to changing priorities.
• Excellent communication and interpersonal skills required.
• Strong attention to detail and organization skills required.
• Candidate must excel at working within a dynamic, hands-on, team-based environment with limited supervision.
• Experience with inspection readiness and interacting with health authorities highly desired.

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.