Quality Recruiting. Established Experts.

Director, Quality Control Operations

Reference Number: 4160
Location: MA

Our client is a leader in the research and early development of human gene-based therapies. They have asked us to assist them in their search for a Director, Quality Control Operations.

Major tasks and responsibilities will include:

  • Maintains a safe, functional and compliant laboratory operation in accordance with GMP SOPs, guidelines, and regulations.
  • Directs the day-to-day management of QC operations.
  • Tests raw materials, in-process samples, drug substance and drug product release/stability and complaint samples.
  • Performs environmental/water monitoring according to SOPs, sample test requests, and as per QA approved protocols and investigations.
  • Oversees timely investigation of OOS, OOT, etc.
  • Responsible for the timely management of Deviations, Change Controls, and CAPA.
  • Oversees maintenance of critical reagents, controls, and laboratory supplies.
  • Outsources testing activities.
  • Reviews and approves of documentation, where applicable.
  • Supports regulatory submissions of INDs, NDAs, etc.
  • Develops, maintains, and continuously improves robust QC systems.
  • Ensures compliance in sample management, testing, data approval, data management and archiving, and validation and calibration of QC equipment.
  • Ensures sample integrity from receipt to completion of testing.
  • Maintains data integrity in order to meet compliance requirements.
  • Ensures method validation and support life cycle management of methods, specifications, stability program, etc.
  • Ensures new equipment are efficiently validated and in operations.
  • Oversees major project milestones and translates them into QC deliverables.
  • Identifies and resolves obstacles to maintain a highly effective, productive, and GMP compliant operations.
  • Ensures timely issue escalation to Quality senior management and cross-functional support teams.
  • Develops, maintains, and continuously improves QC operating practices, QC and cross-functional operations governance team, KPIs, and provides monthly reports to management.
  • Maintains department structure and ensures continued development/training of staff members.
  • Effectively leads the QC team to support strong interactions and partnerships with other departments.
  • Manages and develops the performance of direct reports by setting clear goals.
  • Provides timely performance feedback, recognize and reward high achievers, and improve/address any performance gaps.
  • Supports internal and external inspections and regulatory filings.
  • Develops and manages QC budget to support both yearly and long-term needs of the department.

We seek candidates with the following qualifications:

  • Master’s degree in Virology/Biochemistry/Biology or relevant scientific/engineering discipline required.
  • Must have a minimum of 10 years of pharmaceutical industry experience in GMP Quality Control.
  • Must have a minimum of 5 years of organizational and cross functional team leadership experience, successfully delivering business results.
  • Requires demonstrated knowledge and execution of global regulations, quality systems, and processes in GMP Quality Control testing and operation
  • Local and international travel may be required up to 5%.
  • Advanced knowledge of global, especially US and EU GMP guidelines required.
  • Must have effective communication skills with the ability to interact with all levels the key stakeholders.
  • Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment is required.
  • Requires the ability to apply science and compliance to build robust systems and procedures in QC operations.

If interested, please email your resume as a Word attachment to us, reference 4160.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.