Head of Quality Assurance
Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Head of Quality Assurance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads the Quality Assurance department in all GxP functional areas (i.e., GMP, GLP, GCP, GDP, document control, training, audits, etc.) as development programs transition from early phase through clinical to commercial stages.
- Ensures that quality systems meet standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities.
- Directs, guides, and evaluates performance of direct reports, full time and consultants.
- Oversees the planning and conduct of internal and external audits to ensure compliance with GCP regulatory requirements for clinical trials, adherence to GLP regulations, and GMP/GDP regulatory requirements.
- Hosts and manages, as the primary point of contact, regulatory agency inspections.
- Provides support during regulatory inspections as needed.
- Advises upper management on the implications and risks related to quality issues and important strategic decisions.
- A Bachelor’s degree in a scientific discipline is required, an advanced degree is preferred.
- Must have extensive experience developing and implementing quality systems directly related to biologics manufacturing cGMP/GDP, as well as GCP and GLP activities.
- Requires thorough knowledge of FDA and EMA GCP/cGMP/GLP/GDP regulations, including ICH guidance documents.
- Must have experience in building a culture of quality, compliance, and growth and development in support of regulatory requirements in drug development and enabling the performance and operational excellence for individuals and development teams.
- Requires experience in implementing principles for QRM (ICH Q9, ICH E6 R2).
- Experience with leading a company through pre-approval inspections and QA activities in support of marketing authorization preparation and inspection readiness is required.
- Must understand global drug development activities from R&D to commercialization activities.
- The ability to lead quality professionals, both internal staff and external consultants is required.
- Must be able to demonstrate diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, oversee, and guide the work of other colleagues.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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