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Senior Manager/Associate Director Clinical QA

Reference Number: 3075
Location: MA

Our client is a clinical-stage pharmaceutical company focused on discovery and development of novel first-in-class drugs.  They have asked us to assist them in their search for a Senior Manager/Associate Director Clinical QA.

This person will be responsible for management of the GCP & Pharmacovigilance (GVP) Quality System in compliance with regulations so that the Quality of the company’s products are maintained, the patients’ interests are protected, and the company’s quality objectives are met.  Also, to ensure that the company and outsourced third parties are audit ready at all times.

Major tasks and responsibilities will include:

  • Provides quality oversight for all internal & external clinical quality systems, including CROs, investigator sites, independent studies, and other key partners supporting the company’s clinical programs.
  • Establishes metrics for performance and compliance. Performs Periodic trending of data.
  • Provides quality oversight of external clinical functions.
  • Develops and manages the Audit Master Plans (AMP) and performs audits of clinical investigator sites, data management, and pharmacovigilance internal system and vendors.
  • Plans, schedules, conducts, reports and follows up on GCP/PV related audits.
  • Communicates audit and quality issue investigation outcomes and monitors compliance to regulations and internal procedures.
  • Partners with Clinical, Pharmacovigilance and other R&D functions as appropriate to develop effective corrective actions and preventative actions (CAPAs) to ensure continuous improvement.
  • Manages and confirms CAPA is complete and closed for each audit observation.
  • Approves & Tracks CAPAs and reviews for effectiveness.  Responsible for maintaining evidence records in support of inspection readiness.
  • Contributes to the development and presentation of key quality performance indicators as assigned.
  • Provides GVP and as appropriate other GxP consultation to R&D business partners.
  • Partners with R&D Operations to evaluate R&D systems for optimization and continuous improvement.
  • Participates in the development, review and approval of standard operating procedures.
  • Assists with inspection readiness activities and inspection execution as assigned. Ensures operations in clinical development are compliant with cGCP, GVP FDA, ICH, EMA and industry standards.
  • Reviews of clinical and data operational plans and protocols.
  • Provides support and contributing to other Quality Assurance activities as necessary.
  • Provides consultation in interpretation of regulations/guidelines as they apply to the GCP practice, awareness of regional regulatory requirement, and phase of study/phase of manufacturing process.
  • Promotes a culture of total quality and continuous improvement.
  • Proposes quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based assessments.
  • Serves as an SME for areas of responsibility during regulatory inspections.
  • Supports corporate and third party inspection readiness activities.
  • Oversees records retention and good documentation practices for all GxP.

We seek candidates with the following qualifications:

  • Bachelor’s Degree in Chemistry, Biology, or higher is required.
  • 6-8 years of experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.
  • At least 3 years prior auditing experience required.
  • Ability to work in an entrepreneurial and fast paced culture.
  • Experience in implementation and maintenance of Clinical Quality Systems.
  • Demonstrated knowledge of Quality Systems and cGxP within an FDA and EMA-regulated environment.
  • 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.
  • Must be disciplined, detail orientated and excel in personal time management.
  • Ability to work in teams to achieve compliant, timely and efficient clinical studies and regulatory submission resulting there from.
  • Ability to travel 20% - 40% of the time (domestic and international).
  • Ability to influence and work independently and in a team environment.
  • 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 3075. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.