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Quality Manager - Pharmaceuticals

Rochester, New York, United States
November 30, 2016

Quality Assurance ( QA ) Manager

TxMQ is currently assisting their client in the search for a qualified QA Manager for their FDA regulated manufacturing facility in Western NY due to the promotion of the current Manager.


REPORTING TO: Senior Director of QA


• QA Manager will independently perform duties related to various projects and/ or investigation processes. Typical projects include: new products/technologies, facility construction/renovation, product-line segregation (i.e., hormones and antineoplastic products), and other projects. The incumbent will provide quality & compliance guidance, direction, and focus to the team/investigation and will work within time-lines & budgets to ensure desired outcomes are achieved.


• Ensure projects’ time-lines and budgets are met and any deviations are timely communicated to senior site management.

• Thorough review and analysis of deviations which may include both quality and manufacturing deficiencies.

• Reviews and approves product development reports. i.e.: filter retention studies, product hold times, paraben concentration studies and product stability.

• Approval and analysis for evaluation of defect levels.

• Reviews cleaning validation studies to support the effectiveness of current cleaning programs.

• Provide assistance in troubleshooting in both manufacturing and quality related issues.

• Approval of validation qualifications/ re-qualifications.

• Support new product development and manufacturing initiatives

• Reviews and approves standard operating procedures.

• Approval of environment excursions and anomalies.

• Analyze and approve new manufacturing processes and innovations.

• Performs first of code batch record review.

• Review and approve work orders and critical change request.

• Follow up and monitor action plan effectiveness evaluation and review.

• Approve document change control request.

• Assess, evaluate, and determine compliant course of action for any of the following areas as they relate to project, investigation or process improvement: Engineering, Chemistry, Microbiology, Computer part 11, Solid and Liquid Manufacturing, Sterilization Assurance and Aseptic Manufacturing.

• Responsible for internal documentation meeting minimum cGMP requirements.

• Coordinate with FDA during inspection processes.

• Approve, create and/or revise validation, engineering, laboratory, and database documents to ensure the documentation is accurate, complete, thorough, cGMP compliant, and meets various external requirements (i.e., ISO, GAMP, ISPE, etc.).

• Research, investigate, and provide guidance to the team concerning technology, compliance, quality, and creative solutions to ensure the project or investigation are successful.

• Review and advise on risk assessment for all areas of the facility management, from construction & remodeling to product & cross-contamination impacts.

• Ensure validation activities are performed in accordance with SOPs and regulatory requirements.

• Ensure facility engineering, PM & calibration programs are performed in appropriate & timely manner.

• Ensure investigations are completed in a timely manner and are cGMP compliant.

• Ensure regulatory guidance updates are transitioned into appropriate procedures, practices, policies and activities in a timely manner.

• Ensure validation programs/methods for computer/ laboratory equipment are performed in accordance with SOP’s and other regulatory requirements.

• Review and approve quality documents such as: Batch Records, Product Specifications & Test Methods, Masterplans, IQ/OQ/PQ’s, PV, CV, CSV’s, DQ, URS, FAT/SAT’s, Drawings/P&IDs, and Policies/SOP’s.

• Make Quality Assurance related decisions at a leadership level within the plant from the technical review for various quality areas.


• BS/BA degree is required. 10-15 years of related work experience in a pharmaceutical industry with an emphasis on cGMP are required if no BS/BA degree is attained. At least 7-10 years of industry experience with BS/BA.

• Must possess strong interpersonal and written/verbal communication skills.

• Must be able to interface with Regulatory Agencies, Vendors and other departments across the Company


• The compensation package is competitive and will include an excellent benefits package, bonus and relocation assistance for the right candidate.


• Interested and qualified candidates should submit a Word formatted resume, employment references, and salary history for immediate consideration.

• TxMQ would like to extend thanks to all applicants, however, only those that may qualify for the position will be contacted for a preliminary interview screening.

TxMQ, Inc.

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