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Director/Senior Director of Quality Control

Reference Number: 2814
Location: MA

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Director/Senior Director of Quality Control.

The Director/Senior Director of Quality Control will be responsible for oversight of the Quality Control testing at the Company as well as contract testing labs (CTL) and contract drug substance and drug product manufacturing operations (CMOs).  This includes vendor oversight, project management, data review, external auditing, exceptions management (Deviations, CAPAs), and change control.  The incumbent will oversee designation of critical quality attributes, trending of method performance as well as in process, release and stability data, and setting of specification.  He/she will deploy appropriate process analytical technologies aligned with manufacturing control strategies.  This position directs method transfers and method validation and develops corporate quality systems for laboratory controls.   This includes ensuring that effective Laboratory Controls are established and managed in compliance with regulations so that the Quality of the company’s products is maintained, the patients’ interests are protected, and the Company’s quality objectives are met.

Major tasks and responsibilities will include:

  • Ensures contracted third party testing (CMOs and Labs) are in compliance with appropriate Quality practices to meet the desired quality attributes of the Company and ensures the facilities/Quality Systems will pass regulatory inspections.
  • Oversees method transfers and method validations at contract labs and CMOs.
  • Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
  • Reviews QC raw data from third parties, and generates Certificates of Analysis.
  • Participates in cGMP audits of contract testing labs.
  • Contributes to appropriate sections of Annual Product Review for applicable products.
  • Authors QC sections (e.g., batch analysis, analytical methods, reference standard, etc.) of regulatory filings (CTD/NDA/BLA or IND).
  • Promotes a culture of total quality and operational excellence.
  • Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
  • Serves as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections.
  • Proposes quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
  • Supports corporate and third party inspection readiness activities.

We seek candidates with the following qualifications:

  • A Bachelor’s Degree in Chemistry, Biology, or Life sciences, or equivalent education or experience is required.
  • 15+ years of experience with analytical test method transfer, qualification, and validation including oversight of outsourced testing.  Experience with biologics is a pre-requisite.  Work with small molecules/pharmaceuticals is preferred.
  • Experience in implementation and maintenance of laboratory information management systems.
  • Demonstrated success in preparation of regulatory submissions to support first in human studies as well as commercial licensure.
  • Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
  • Seasoned professional with broad experience and demonstrated success in interacting with regulatory health authorities during review of regulatory filings as well as during inspections.
  • Must be well organized and able to grasp system concepts and communicate their applications.
  • Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
  • Ability to handle multiple assignments in a fast-paced environment with changing priorities.
  • Competency in MS Office, Adobe Acrobat, and data analysis tools (e.g., JMP or MiniTab).
  • Ability to travel up to 25% of the time.
  • Excellent communication skills, in both verbal and written form.
  • Ability to influence others and work independently and in a team environment.
  • Leadership, negotiation and conflict management skills.

 

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 2814. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.