Quality Assurance (QA) Specialist / Manager – DMPK
Location: Exton, PA
Department: DMPK (Drug Metabolism & Pharmacokinetics)
Reports To: Senior VP, DMPK
Employment Type: Full-Time
Company
Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, 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 Summary
We are seeking a highly motivated Quality Assurance (QA) Specialist/Manager to support and strengthen quality systems across our growing DMPK organization, including quality oversight, inspection readiness, SOP management, training programs, auditing activities, data integrity initiatives, and archival systems.
This position offers an excellent opportunity for an experienced quality professional to help shape and enhance quality processes within a dynamic scientific environment.
Roles and Responsibilities
Quality Systems & Compliance
- Support and maintain DMPK quality systems and compliance programs.
- Ensure compliance with GLP regulations, company SOPs, client requirements, and industry best practices.
- Promote quality culture and continuous improvement throughout DMPK operations.
- Support quality oversight of both GLP and non-GLP studies.
Audits & Inspections
- Plan, conduct, and report internal audits of laboratories, facilities, studies, processes, and documentation.
- Support/host sponsor audits, regulatory inspections, and client visits.
- Coordinate responses to audit observations and inspection findings.
- Assist with inspection readiness programs and mock audits.
- Conduct outside vendor audits as may be required, including laboratories and services for subcontracting and/or supporting services, and follow-through on any quality issues
SOP & Document Control
- Manage SOP lifecycle activities including drafting, review, approval, revision, and periodic review.
- Maintain document control systems and ensure compliance with document management procedures.
- Work with scientific teams to establish and improve quality procedures and work instructions.
- Coordinate employee training programs and maintain training records.
- Track compliance with required quality and technical training.
Data Integrity & Documentation Review
- Review study documentation, notebooks, reports, worksheets, and electronic records for compliance and completeness.
- Participate in investigations involving deviations, documentation issues, and compliance concerns.
Archive & Records Management
- Oversee archival and retrieval of study records, reports, raw data, and electronic files.
- Ensure compliance with record retention requirements.
- Coordinate archive activities with internal and external storage providers.
- Support long-term data preservation and retrieval processes.
Education and Requirements
Education
- Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacology, Pharmaceutical Sciences, or a related field.
- Advanced degree is a plus.
Experience
- 5+ years of QA, QC, GLP, or regulated laboratory experience in CRO, pharmaceutical, biotechnology, or related industries.
- Experience supporting GLP studies and quality systems preferred.
- Experience in DMPK, ADME, bioanalysis, or related scientific disciplines is highly desirable.
Knowledge & Skills
- Strong knowledge of GLP regulations and quality systems.
- Familiarity with data integrity principles and regulatory expectations.
- Excellent organizational, communication, and problem-solving skills.
- Strong attention to detail and ability to work independently.
- Experience with document management systems and electronic records preferred.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.
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.
Skills Required
- Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacology, Pharmaceutical Sciences, or related
- Advanced degree (MS/PhD)
- 5+ years QA, QC, GLP, or regulated laboratory experience in CRO, pharmaceutical, or biotechnology environments
- Experience supporting GLP studies and quality systems
- Experience in DMPK, ADME, or bioanalysis
- Strong knowledge of GLP regulations and quality systems
- Familiarity with data integrity principles and regulatory expectations
- Experience with document management systems and electronic records
- Experience planning, conducting, and reporting internal and vendor audits; supporting sponsor audits and regulatory inspections
- Experience managing SOP lifecycle, training programs, and archival/records management
- Excellent organizational, communication, problem-solving skills, attention to detail, and ability to work independently
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
