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Id: 178677 Location: Exton, PA Job Type: Direct Hire Our client, a Global Clinical Research Organization is looking for a B ioanalytical Quality Assurance Manager with 5+ years BIO, GLP, QA experience in the pharma industry and management experience.

This role is a Direct-Hire opportunity reports directly to the Sr. Director of Quality Assurance located in Exton, PA office. We also have multiple QA opportunities with other global pharmaceutical and medical device companies located in NJ/PA areas. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at #610-###-#### for questions.

***Please forward your resume (word document) directly to ...@gesnetwork.com or call Rose Chu at 610-###-#### for questions***

Quality Assurance Manager, BIO/GLP

Duties and Responsibilities:

Implement, maintain and enhance quality procedures and systems to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320 , and other relevant guidances and publications.
Assist the Sr. Director with client audits / regulatory inspections and as back-up in their absence
Assist with client RFIs and requests
Assist the Sr. Director with audit schedules
Conduct QA audits of bioanalytical laboratories and functions including but not limited to: ongoing process, data review audits, technical report, and study independent facility / process .
Provide input to method, equipment, computer validation programs.
Maintain GLP Master Schedule .
Maintain appropriately detailed notes, audit reports, and records
Provide input to documentation and data storage systems .
Ensure that requirements and documentation for all GLP systems are kept current according to ever-changing guidelines and industry standards.
Provide GLP training to staff as necessary.
Provide oversight and input to analytical and process investigations, CAPA and calibration programs, specifications, and supplier selection processes.
Conduct outside vendor audits as may be required, including contract laboratories and raw material suppliers ; resolve and follow-through on any quality issues.
Review and maintain up-to-date Standard Operating Procedures (SOP).

Requirements

BS in Chemistry, or other related discipline
Five (5) years BIO ( bioanalytical) , GLP (Good Laboratory Practice) , QA (Quality Assurance) experience in the pharma industry
Must also have management experience.

Search Terms: Quality Assurance Manager, Associate Director, Quality Assurance, QA Director, Clinical QA Manager, GLP, BIO, quality procedures, US FDA, OECD, and ICH, 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, RFIs, audit schedules, QA audits of bioanalytical laboratories, GLP Master Schedule, GLP systems, GLP training, analytical and process investigations, CAPA and calibration programs, specifications, and supplier selection processes, vendor audits, contract laboratories, raw material suppliers; quality issues, SOP, Bioanalytical QA Manager

We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc- Sr. Accountant ) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format, in confidence, to: Rose Chu at ...@gesnetwork.com or call Rose Chu at 610-###-#### for discussion.

Rose Chu

Vice President - Pharmaceutical, CRO, Biotech, Medical Device

Global Employment Solutions/Fahrenheit IT

P (610)###-#### | C (215)-###-#### | F (610-###-####) | ...@gesnetwork.com

One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004

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Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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