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Director of QA Engineering, Operations

Reference Number: 2835
Location: RI

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Director of QA Engineering, Operations.

The Director of QA Engineering, Operations is responsible for QA oversight for all engineering activities at our client’s manufacturing facility for commercial and clinical products.  The QA responsibility includes oversight of process engineering, facilities and utilities engineering, and process automation.  This role acts as the QA operations lead and advisor for clean-in-place and sterilize-in-place design, equipment, utilities, and general engineering practices and procedures.  This position provides QA management support for complex deviations, CAPA and change controls for systems and processes related to facilities, engineering, automation, validation and manufacturing process equipment.  The Director QA Engineering, Operations analyzes and solves complex problems, implements solutions, and guides large scale projects and programs on a regular basis.  The position will provide QA oversight for all engineering projects that require modifications to facilities, utilities, systems and equipment (FUSE).  Success is measured by projects that are implemented compliant with regulations and that have no unintended consequences to FUSE due to robust, proactive risk assessments.  The Director is expected to perform all duties in compliance with Good Manufacturing Practices (cGMP) and in accordance with company policies, procedures, and federal regulations.

Major tasks and responsibilities will include:

  • Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
  • Responsible for being QA Operations management lead contact and primary Subject Matter Expert (SME) for complex engineering matters related to utilities, process equipment, process automation, CIP and SIP design, and facility/system design.
  • Effective at influencing decision makers both internally and externally.
  • Supports and reviews complex deviation investigations, Corrective Work Orders, Risk Assessments, CAPAs and Change Controls related manufacturing process equipment, utilities, automation, validation, and engineering.
  • Provides Engineering Subject Matter Expertise and is approval authority on behalf of QA Operations Management for the release of equipment, systems and/or facility based on completion of corrective actions related to a complex deviation, corrective work order, validation, or change control.
  • Effectively collaborates with customer and supporting departments (Operations, Facilities, Manufacturing, Automation, Validation, Engineering and Quality Control) to resolve open issues resulting from equipment malfunctions using the company’s Quality Systems.
  • Provides QA Management oversight to equipment lifecycle process activities including commissioning, requirements identification, equipment impact and criticality assessments, design review, construction, qualifications, calibration and preventive maintenance.
  • QA Operations Management review and approval of engineering drawings, engineering test plans, engineering technical reports, Standard Operating Procedures, protocols, and reports.
  • Provides training to site personnel and contractors on GMP and the Quality System procedures.
  • Leads the identification and implementation of improvement opportunities for issues related to automation, equipment and validation.
  • Maintains a high, and continuously improving, level of cGMP compliance to ensure patient safety and to minimize risk to the company business.  Supports Regulatory licensure activities, including agency inspections.  Provides expertise and leadership in formulating inspection responses.
  • Motivates, recruits and develops key employees.  Builds and sustains employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Maximizes the success rate for production operations by supporting programs to minimize mechanical failure, closed-system breaches, and procedural errors.  Supports strategic plans for process and plant improvements in order to increase efficiency and compliance.

We seek candidates with the following qualifications:

  • Bachelor’s degree in chemical or mechanical engineering or related field required; preference given to candidates with advanced degrees in chemical or mechanical engineering or related fields.
  • 12+ years of experience managing QA and/or Engineering function for a GMP facility in the biotechnology industry; 10 years of direct QA experience preferred.
  • Deep knowledge of regulatory requirements for clinical and commercial biopharmaceutical facilities.
  • Ability to apply fundamental engineering principles to resolve issues relating to utilities, process equipment, process automation, CIP and SIP design, and facility/system design.
  • Experience managing complex deviation investigations and use of Trackwise system.
  • Must be able to prioritize critical versus non-critical issues, communicate critical issues to management and team leaders in clear and timely manner.
  • Demonstrated leadership skills in developing, motivating, and organizing high performance work groups in the biotechnology industry.
  • Excellent technical skills with solid understanding of manufacturing equipment in the biopharmaceutical facility.
  • Excellent communication skills – both upwards and downwards and outside of company.  Ability to lead and communicate orally, in written documents, and in formal presentations required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2835. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.