Director, Clinical QA Compliance - REMOTE job in Chicago, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)

Location: United States

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

Proclinical is seeking a remote Director, Clinical QA Compliance with a biotechnology company. The role will consist of ensuring that a proactive, risk-based Quality Strategy is established and implemented for the clinical development activities within a portfolio.

Job Responsibilities:

Manages a pro-active risked based quality oversight on the clinical trial process in order to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, Good Clinical Practices and other applicable GXPs, internal standards and adherence to patients' safety, rights and wellbeing.
Ensures QA expertise and proactive guidance are provided to clinical trial teams, to ensure that high priority programs and quality initiatives meet defined expectations.
Lead a team of QA personnel located in different geographical locations and ensure the values of transparency, speak up, and pro activity are embedded as part of the vision of the team.
Proactively provide strong QA leadership to the Development organization by ensuring considerable organization awareness (e.g., interrelationship of departments and business priorities).
Ensure the implementation of the Clinical Development Quality Plan within the development portfolio.
Provide robust quality oversight in the following areas:
- Proactively support / collaborate with key stakeholders to ensure that risks are detected and remediated
- Provide guidance to day-to-day questions arising from Clinical trials deliverables
- Collaborate with Clinical Development Operations to drive initiatives relevant to outsourced activities
- Support inspections preparation and facilitation in collaboration with other QA groups.
- Support audits and inspections follow-up activities including CAPA preparation
Manage a team to ensure one aligned approach is taken for implementing a proactive approach in support of clinical trials.

Skills and Requirements:

At least 8 years of experience in a GCP Environment in the Pharmaceutical or CRO Industry
In depth expertise in worldwide regulations (including FDA, EMA) related to clinical development and post approval.
Multiple years of experience in Quality functions such as auditing / compliance
Typically requires an academic degree in Life Science (advanced degree preferred)
Experience managing global communities

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.

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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