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Experienced Quality Assurance Director with a demonstrated history of working in the pharmaceutical manufacturing and health care industry. Strong quality assurance professional skilled in Verification and Validation (V&V), Change Control, FDA Compliance, GMP, Quality Systems, and Quality Assurance.
Olympus Corporation Of The Americas
View- Website:
- olympus-global.com
- Employees:
- 13431
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Principal Compliance EngineerOlympus Corporation Of The AmericasMemphis, Tn, Us
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Principal Compliance EngineerOlympus Corporation Of The Americas Aug 2020 - PresentCenter Valley, Pennsylvania, Us -
Director Of Quality AssuranceTriad Life Sciences Aug 2018 - Aug 2020Memphis, Tennessee, UsResponsible for oversight of Quality Systems to ensure compliance with applicable sections of Title 21 CFR Part 1271, Part 820, Part 11, and ISO 13485. Specific responsibilities and accomplishments include:• Development, implementation, and administration of Quality Systems including:• Change Control• Design Control• Exception Management (Nonconformance, Complaints, CAPA)• Training• Process Validation• Supplier Quality -
Quality Systems ManagerPharmedium Services Jan 2018 - Aug 2018Lake Forest, Il, UsResponsible for oversight of Quality Systems to ensure compliance with applicable sections of Title 21 CFR Parts 1300 – 1317 and Part 211. Specific responsibilities include:• Leadership of Quality Systems team:• Management of Quality staff responsible for DEA reporting requirements including chain of custody, destruction, and loss, theft, or diversion of controlled substances• Management of staff responsible for tracking and trending of Quality metrics• Facilitate and participate in cross-functional team to complete investigations -
Senior Quality EngineerFresenius Medical Care North America Nov 2015 - Jan 2018Bad Homburg, Frankfurt, DeResponsible for oversight of Quality Systems to assure compliance with Title 21 CFR Part 211, Part 820, and ISO 13485. Specific responsibilities include:• Develop and implement key quality systems including:• Exception Management ( Nonconformance, Planned Variance)• Document Management• Training Management• Calibration Management• Acceptance Sampling• Good Documentation Practices• Led team managing the development and implementation of production, packaging, labeling, materials, facilities, equipment, quality, and laboratory control systems (implementation of approximately 575 documents) for start-up of facility• Supervise Documentation team including:• Management of validation documents/records• Management of calibration system• Management of Exceptions• Management of document change control -
Regional Quality ManagerSiemens Healthcare Dec 2011 - Nov 2015Forchheim, DeResponsible for Quality oversight of nine radiopharmaceutical manufacturing sites including dotted line reporting relationship for the Quality Systems Officer at each site. Specific responsibilities include:• Develop / Re-engineer quality systems including OOS, Notice of Event (NOE), internal assessment, and supplier quality to meet the requirements of Title 21 CFR Part 212• Perform assessments of sites’ overall compliance status with regard to Title 21 CFR Part 212 and internal standard operating procedures• Review and approval of investigations (deviations, OOS, etc.) associated with product release testing, including chromatography, endotoxin, and sterility• Support for inspections by regulatory agencies and customers including multiple FDA pre-approval inspections• Support corporate efforts for implementation and harmonization of quality systems at all manufacturing sites• Develop procedure to define roles and responsibilities for regulatory inspections• Develop Supplier Approval procedure aligned to meet requirements of Title 21 CFR Part 212 -
Technical Services ManagerPharma Packaging Solutions Sep 2011 - Dec 2011• Develop Technical Transfer• Develop validation documents (IQ, OQ, PQ) for equipment, facilities and utilities• Component and Packaging Specifications development/approval
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Quality ManagerPharma Packaging Solutions Aug 2004 - Sep 2011Managed and effected key quality systems including: •Supplier Quality (Supplier Assessment, Supplier Management, and Supplier Nonconformance Resolution) •Quality Metrics and Management Review •Document Management •Calibrations •Training Management •Exception Management (Complaints, Nonconformance, and Planned Variance) •Environmental Monitoring (Cleanrooms and USP Controlled Room)Support for inspections by regulatory agencies and customersManage Quality Systems team including training, batch release, in-process control, and incoming material controlQuality Engineering and Statistical SupportInternal Audit/Assessment
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Quality EngineerSchering-Plough Jun 1984 - Jul 2004
Tim Whaley Skills
Tim Whaley Education Details
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University Of Tennessee, KnoxvilleBusiness Administration -
Cleveland State Community College
Frequently Asked Questions about Tim Whaley
What company does Tim Whaley work for?
Tim Whaley works for Olympus Corporation Of The Americas
What is Tim Whaley's role at the current company?
Tim Whaley's current role is Principal Compliance Engineer.
What is Tim Whaley's email address?
Tim Whaley's email address is ti****@****ast.net
What is Tim Whaley's direct phone number?
Tim Whaley's direct phone number is +186532*****
What schools did Tim Whaley attend?
Tim Whaley attended University Of Tennessee, Knoxville, Cleveland State Community College.
What skills is Tim Whaley known for?
Tim Whaley has skills like Validation, Gmp, Quality Systems, Sop, Process Validation, Cgmp, Quality Control, Technology Transfer, Fda, Supplier Quality, Quality Assurance, 21 Cfr Part 11.
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