Quality Assurance Manager – GLP Position Available In Chester, Pennsylvania
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Job Description
Position:
QA Manager –
GLP Location:
Exton, PA Salary:
$100,000 – $125,000 D.O.E. Unfortunately, we cannot support work permit applications for this role. Are you ready to embark on an exhilarating journey with a team that’s passionate about making a difference? Pharmaron is thrilled to invite you to join us as our Quality Assurance Manager at our Exton GLP facility! If you’re craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you’ve been waiting for.
Job Overview:
As a GLP experience Quality Assurance Manager, you will be responsible for the oversight of the Quality Systems supporting the GLP Laboratories.
Responsibilities:
Lead and Support the
Quality Team:
Manage a team responsible for key GLP Quality Systems, including Deviations, Change Control, CAPA, Risk Assessments, Computer System Validation, Archiving, and Training.
Oversee Quality Reviews and Audits:
Ensure timely review of client data and conduct QA audits of Master Study Protocols, Bioanalytical Phase Plans, and Final Reports, keeping client deadlines in mind.
Build Strong Client Relationships:
Work closely with clients to understand and meet their GLP Quality needs, ensuring compliance with Quality Agreements where applicable. Deliver on
Client Expectations:
Collaborate with clients to ensure all deliverables meet agreed timelines and quality standards.
Drive Quality Improvements:
Identify and resolve quality issues and lead initiatives for continuous improvement.
Monitor and Report Quality Metrics:
Track key quality indicators and share insights with executive leadership to support ongoing improvement efforts. Promote a
Quality-First Culture:
Foster a culture of quality across the site by providing leadership and coaching to embed GLP best practices throughout operations.
Support Scientific Teams:
Partner with scientific departments to help them deliver client projects that meet or exceed regulatory standards.
Lead Improvement Projects:
Take the lead or support continuous improvement initiatives across all GLP functions.
Manage Audits and Inspections:
Lead or support
GLP/GCLP/R D
client audits and regulatory inspections.
Ensure SOP Compliance:
Enforce adherence to Standard Operating Procedures (SOPs) across teams.
Communicate Effectively:
Maintain clear and professional communication with colleagues, leadership, and clients.
What We’re Looking For:
We’re seeking a highly experienced and detail-oriented Quality Assurance professional to join our team. The ideal candidate will bring a strong background in GLP and GMP environments, with a proven track record of ensuring compliance, driving quality improvements, and supporting regulatory readiness. You’ll be a confident communicator, a meticulous reviewer, and a collaborative team player who thrives in a regulated, fast-paced environment.
Essential Qualifications and Experience:
Bachelor’s degree in a scientific discipline, preferably biology or a related field At least 5 years of direct QA experience in the pharmaceutical or biotechnology industry within a GLP environment Several years’ experience in a regulated GMP or GLP setting Strong working knowledge of GLP regulations (21 CFR Part 58, OECD
GLP, ICH
guidelines) Experience writing and reviewing SOPs, Master Study Protocols, and Final Reports Skilled in GLP analytical data review and conducting study audits Experience leading or supporting regulatory inspections Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. “Employees Number One” and “Clients Centered” are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program How to
Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-ZS1