(Sr) Manager, Clinical Quality Assurance Compliance job in Boston, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is working with a leading biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Our client is urgently searching for a Remote (Senior) Manager of Clinical Quality Assurance Compliance to join the Clinical Quality Assurance (CQA) group. The qualified individual should have experience with US and international GCP/PV/GCLP regulations, guidance documents, and industry best practice in all areas of a GxP environment.

Job Responsibilities:

Participates in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management.
Works with internal and external GCP/PV entities and develop and execute strategic audit plans.
Supports the development and/or review of GCP/PV audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
Supports the development, implementation and maintenance of CQA systems and SOPs for GCP/PV systems
Leads internal and external audits of the various quality elements to ensure compliance to GCP/PV/GCLP regulatory commitments and requirements, industry best practices and guidances
Act as a contact with members of Regulatory Authorities and / or vendors; assist and lead inspections / audits, in agreement with QA management.
Participates in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
Performs final quality review/assessment for new Clinical Vendors/CROs
Trains and mentors junior staff
Independently writes and implements controlled documents (i.e., SOPs, Policies, Audit reports) which may entail significant system changes
Stays current with changes to current GCP/PV/GCLP regulations, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies so that NVAX's compliance policies are current and effective.

Skills and Requirements:

Bachelor's degree in biological science is required.
8+ years' experience in GXP pharmaceuticals, biologics and/or vaccine clinical research.
5+ years industry experience in an auditing role
CQA/RAPS or other audit certification is highly preferred.
Knowledgeable in principles and current GCP/PV/GCLP in a clinical development to commercial application setting.
Excellent multi-tasking, analytical, organizational and teamwork skills.
Ability to troubleshoot, identify root cause and systematically resolve problems.
Ability to communicate clearly and effectively with all levels of the organization.
Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.
Individual must be willing to travel domestically and internationally (30-50%), as needed.
Produces high-quality work on complex problems with cross-functional involvement. Anticipates and proactively prevents risks and compromises to quality

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968.

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

Proclinical Staffing is an equal opportunity employer.

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