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Senior Manager - Quality Pharmacovigilance

Reference Number: 2892
Location: NY

Our client is a rapidly growing biotechnology company.  They have asked us to assist them in their search for a Senior Manager - Quality Pharmacovigilance.

The Senior Manager - Quality Pharmacovigilance is responsible for performing domestic and international inspections that ensure compliance with the FDA and other worldwide health authority Drug Safety and PV regulations and guidelines, site SOPs, protocols, and industry standards, as applicable.  This individual provides recommendations for corrective and preventative action and tracks corrective action commitments until closure.

Major tasks and responsibilities will include:

  • Plans and conducts document, internal and external GPvP audits to assess compliance with FDA and applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations as applicable.
  • Audits and evaluates service providers, as appropriate, to assess capabilities and compliance with applicable regulations, contractual obligations as well as with company policies and procedures.
  • Prepares clear and concise written reports of audit observations, including an assessment of compliance.
  • Presents QA findings to in-house client staff and, if appropriate, to the responsible individuals at service providers.
  • Works closely with Drug Safety and Risk Management (DSRM) staff and Service Providers to identify, evaluate, and recommend solutions to issues identified in the performance of GPvP audits.
  • Evaluates responses and corrective and preventative action plans to audit findings for adequacy and timeliness, reviews implementation, and manages the closeout of all corrective and preventative actions.
  • Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate.
  • Reviews internal and external SOPs.
  • Maintains Quality documentation files, databases and logs.
  • Tracks metrics and trends as well as compliance issues and their resolution on a periodic basis.
  • Participates on Process Improvement teams.
  • Acts as a key point of contact for staff, providing information and expert guidance on GPvP regulations and procedures to associates.
  • Ensures project deadlines and performance standards are met.
  • Ensures compliance with all of the company’s policies and procedures, including safety rules and regulations.
  • Works with the head of Quality to assure alignment and compliance with the company’s Quality Management System, to support assessment of compliance and defines metrics to determine performance objectives.
  • Provides support during compliance inspections conducted by external sources (i.e. health authorities) at company, as applicable.
  • Provides audit related metrics to Senior Management.

We seek candidates with the following qualifications:

  • Bachelor’s degree in life sciences or related field required.  Master’s degree in life sciences or related field preferred.
  • Minimum of seven years of experience in the regulatory compliance environment.  Minimum of five years of Quality auditing experience in the Biotechnology or Pharmaceutical industries required.
  • Strong knowledge of FDA regulations and ICH guidelines related to GPvP is required.
  • Knowledge of EMA and other Health Authority requirements highly desired.
  • Must be able to interpret and apply GPvP regulations, including 21CFR part 11 requirements.
  • Maintains professional expertise and knowledge of local and international regulations related to Quality and GPvP.
  • Must be proficient in MS Office Suite.
  • Excellent verbal and written communication and presentation skills.
  • Excellent organizational skills and attention to detail are essential.
  • Ability to prioritize and multi-task successfully in a fast-paced environment.
  • Ability to review documentation, processes and procedures as they relate to pharmacovigilance activities, to identify issues/problem areas, assess compliance and communicate findings to the appropriate team(s) and management.
  • Ability to work both independently and in a collaborative team setting.
  • Demonstrated leadership and project management skills.
  • Ability to participate on interdepartmental teams.
  • Ability to interact effectively with all levels of associates both internally and externally.

 

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 2892. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.