Associate Director, QA

Associate Director, Quality Assurance

Kelly Science and Clinical has an opening for an Associate Director, Quality Assurance for an engagement at one of our leading pharmaceutical clients in Malvern, PA. The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, and 401K. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Schedule : Mon-Fri, 8AM-5PM

Location : Malvern, PA

Duration : Direct Hire

Compensation : $110,000-$120,000

Position Summary

The Associate Director, Quality Assurance leads quality oversight for a designated laboratory site. The role ensures that nonclinical and clinical bioanalytical data meet applicable GLP, GCP/GCLP, GMP and other regulatory requirements. This position serves as the site's quality lead for regulatory inspections and sponsor audits and partners with the organization’s global QA team to maintain harmonized SOPs, audit practices and data integrity standards across the laboratory network.

Key Responsibilities

Quality Leadership and Team Management

• Lead, develop and manage the site QA team. Set priorities, balance workload and coach auditors toward independent audit and inspection support.

• Act as the senior quality authority on site. Advise laboratory leadership, study directors and principal investigators on regulatory expectations and quality risk.

• Track and report quality metrics, including audit findings, CAPA aging, deviation trends and audit cycle times, to site and global leadership.

Audit Program

• Own the site's risk-based audit program, including study-based inspections, facility and process audits, and data and report audits for GLP and regulated clinical studies.

• Ensure that QA statements and audit reports are issued on time in support of study plans, validation reports and final bioanalytical reports.

• Oversee vendor and supplier qualification audits, including reference standard suppliers, critical reagent vendors, archive providers and computerized system vendors.

Regulatory Inspections and Client Audits

• Host and coordinate FDA, EMA, MHRA and other regulatory agency inspections, as well as sponsor audits and qualification visits. Manage inspection logistics, front-room and back-room activities, and responses.

• Lead the investigation and response to regulatory observations and ensure that commitments are completed on schedule.

• Maintain continuous inspection readiness through internal readiness assessments and mock inspections.

Quality Systems

• Oversee deviation, investigation, CAPA, change control and effectiveness-check processes. Ensure that root-cause analysis is rigorous and documented.

• Review and approve SOPs, policies and quality documents. Work with global QA colleagues to maintain alignment across the organization’s laboratory network.

• Support computerized system validation or computerized system assurance activities for LIMS, chromatography data systems and other GxP systems. Ensure compliance with 21 CFR Part 11 and Annex 11.

• Champion data integrity and ALCOA+ principles through training, audit-trail review expectations and a culture of transparent reporting.

• Oversee GxP training compliance and deliver regulatory and quality training to laboratory staff.

Global Collaboration and Client Support

• Partner with QA colleagues across international laboratory sites on harmonized practices, cross-site method transfers and global audit coverage.

• Support business development and project management with sponsor quality questionnaires, quality agreements and client communications.

Qualifications

Required

• Bachelor’s degree in chemistry, biology, biochemistry, pharmaceutical sciences or a related life science field.

• At least 8 years of experience in a regulated pharmaceutical, biotechnology or contract research organization environment, including at least 5 years in quality assurance.

• At least 2 years of people leadership experience, including direct management of QA professionals.

• Deep working knowledge of 21 CFR Part 58, OECD GLP principles, ICH E6 GCP and 21 CFR Part 11. Familiarity with ICH M10 and FDA and EMA bioanalytical method validation guidance.

• Direct experience hosting or supporting regulatory agency inspections and sponsor audits.

• Strong understanding of bioanalytical workflows, including LC-MS/MS and/or ligand-binding assays, and the data lifecycle from sample receipt through final reporting.

• Excellent written and verbal communication skills, with the credibility to influence scientific and executive stakeholders.

Preferred

• Advanced degree, such as an MS or PhD, in a scientific discipline.

• Prior QA experience at a bioanalytical CRO or central laboratory.

• Exposure to GCLP, 21 CFR Part 211 GMP or ISO 17025 for analytical and CMC testing.

• Computerized system validation or computerized system assurance experience with Watson LIMS, Analyst/SCIEX OS, Empower.

• RQAP-GLP/GCP or ASQ CQA certification.

• Experience working across multinational sites and time zones.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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