Quality Compliance Specialist
ProClinical is currently recruiting on behalf of a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit a Quality Compliance Specialist to work in Cambridge, MA. The organisation offers an excellent rate of pay and have a strong reputation as an excellent company to work for.
- Manage projects and initiatives within the Oncology & Biologics Quality organization to ensure Quality Compliance with GxP regulations and quality/technical agreements.
- Develop and manage relationships with other Oncology &Biologics departments, Alliance Partners and Affiliates to ensure compliance with corporate and regulatory requirements for all business matters.
- Drive the successful execution of regulatory body visits, both internally and externally at Contract Manufacturing Organizations (CMOs), by managing pre-inspection activities, overseeing the fulfilment of requests during the inspection, and coordinating post-inspections activities as assigned.
- Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
- Conduct strategic analysis of O&B manufacturing-related quality metrics to identify any risks, improvement opportunities and/or compliance concerns. Drive resolutions to conclusion by leading or supporting continuous improvement initiatives.
- Coordinate logistic activities related to the O&B Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.
- Oversee any required corrective actions resulting from self-assessments or inspection readiness activities.
- Maintain Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals and generation of the Approved Supplier List.
- Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of O&B Quality & Operations departments.
- Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.
- Engage in cross-functional teams as a Compliance subject matter expert.
- Act as lead trainer for training initiatives of O&B Quality and Operations employees for audit/inspection-related logistic activities.
- Serve as a liaison between Global Regulatory Affairs, Commercial Submissions Management, LOCs and CMOs to support new drug applications and provide inspection supervision for product approval in ex-U.S. countries.
- Identify and escalate regulatory issues and trends pertinent to products and O&B business to management, as appropriate.
- Provide pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).
- Act as training facilitator, as assigned, on department-specific procedures and systems.
- Receive overall project direction from management but completes most work independently.
- Independently write new O&B procedures and revise existing procedures.
- Complete required training and keep training files current.
Skills and Requirements:
- Bachelor of Science (BS) degree and 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, and superior at teamwork and collaboration.
- Excellent organizational, presentation development and delivery skills.
- Proficient computer, verbal and written communication skills.
- Strong problem solving and data analysis skills.
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 Corrin Pyle on +1 267-435-8555 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.
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