Quality Compliance Specialist III

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Cambridge, Massachusetts
Posting date: 19 Feb 2019

ProClinical is advertising a vacancy for a Quality Compliance Specialist III position with a leading international pharmaceutical company that specialises in multiple therapy areas. This prestigious organisation is seeking for the incumbent to join their team in Massachusetts.

The Quality Compliance Specialist III will manage projects and initiatives within the Oncology & Biologics (O&B) organisation to ensure Quality Compliance with GxP regulations and quality/technical agreements. They will develop and manage relationships with other O&B departments, Alliance Partners, and Affiliates to ensure compliance with corporate and regulatory requirements for all business matters. Finally, the Quality Compliance Specialist III will drive the successful execution of regulatory body visits, both internally and externally at Contract Manufacturing Organisations (CMOs) by managing pre-inspection activities, overseeing the fulfilment of requests during the inspection, and coordinating post-inspection activities as assigned.

Job Responsibilities:

  • Ensuring consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU, and Japan.
  • Conducting strategic analysis of O&B manufacturing-related quality metrics to identify any risks, improvement opportunities, and/or compliance concerns.
  • Driving resolutions to conclusion by leading or supporting continuous improvement initiatives.
  • Coordinating logistic activities related to the O&B Quality Self-Assessment program and executing assessments with guidance from Quality Compliance management.
  • Overseeing any required corrective actions resulting from self-assessments or inspection readiness activities.
  • Maintaining Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals, and generating the Approved Supplier List.
  • Participating as an integral member of the Inspection Readiness team.
  • Providing support during all internal, vendor, and Alliance/Corporate Partner compliance or regulatory audits/inspections of O&B Quality and Operations departments.
  • Performing weekly monitoring of quality systems for any adverse compliance trends and escalating any risks to management.
  • Engaging in cross-functional teams as a Compliance subject matter expert.
  • Acting as a lead trainer for training initiatives of O&B Quality and Operations employees for audit/inspection-related logistic activities.
  • Serving as a liaison between Global Regulatory Affairs, Commercial Submissions Management, LOCs and CMOs to support new drug applications and providing inspection supervision for product approval in ex-U.S. countries.
  • Identifying and escalating regulatory issues and trends pertinent to company products and O&B business to management, as appropriate.
  • Providing pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).
  • Acting as a training facilitator, as assigned, on department-specific procedures and systems.
  • Independently writing new O&B procedures and revising existing procedures.
  • Completing required training and keeping training files current.

Skills and Requirements:

  • A Bachelor of Sciences degree.
  • At least 3 years' experience in QA or related compliance area in the pharmaceutical/biotech industry.
  • Knowledge of cGMP regulations for US, EU, and other markets.
  • Effective time management, detail-oriented work style.
  • Able to handle multiple tasks concurrently and in a timely fashion.
  • Good interpersonal skills, including communication, persuasion, and leadership.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kevin Cassini on +1 215 531 5288 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.