The Site Head of Quality is responsible for building, implementing, and maintaining quality assurance systems and processes that comply with FDA and GxP requirements. They must oversee and execute all aspects of the strategic quality plan across GxP applications and quality system functions. This role will also interface with internal teams, clients, regulators, and other facilities throughout the US.
Essential duties of the Site Head of Quality include, but are not limited to:
- Quality representative on the site leadership team.
- Collaborating with operational and quality staff on other sites to execute harmonization plans for global processes and procedures to be implemented and maintained at the Maryland facility.
- Planning and directing resources and activities of the quality assurance and compliance functions.
- Serving as system owner for a global QMS functions.
- Hosting client, external regulatory agency, and notified body assessments and inspections (example: FDA, CAP).
- Leading inspection readiness activities; managing the Quality System and supporting the quality functions of all critical operations.
- Reviewing and approving quality system activities.
- Serving as the site management representative.
- Contributing to the evaluation and mitigation of program risks and escalation of potentially significant quality issues.
- Advising staff to help meet established schedules or resolve technical or operational problems.
The Site Head of Quality must possess:
- Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field.
- 8 years of experience as a Quality professional in the biotechnology or life science, regulated environment.
Other required qualifications include:
- Excellent knowledge of medical research processes, laboratory testing protocols, companion diagnostics, and safety requirements.
- Strong understanding of medical data collection, record keeping, and reporting requirements.
- Experience interpreting and complying with world-wide cGxPs with an emphasis on GMP, GCP, GLP, GCLP, and blood establishments.
- Experience auditing and interacting and relationship building with the public (vendors and clients).
- Proficiency with common computer applications such as MS Office and other relevant industry computerized systems.
- Ability to read, write, speak, and comprehend the English language.
Preferred qualifications for the Site Head of Quality position include:
- Master’s degree in Physical, Biological Sciences, or technical/scientific field, as well as ASQ or SQA certification.
This role may involve extended business hours, occasional domestic or international travel, including overnight stays (up to 20%), and is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
To Apply for the position of Site Head of Quality, or to find out what other opportunities we can offer in the life sciences sector, please either use the form on the right or contact us on +44 (0) 1252 938 100 or ContactUs@centrelineresourcing.com at Centreline Resourcing. You can also find our currently advertised jobs at https://centrelineresourcing.com/jobs/ or check out our LinkedIn page at https://www.linkedin.com/company/centreline-resourcing/