Quality Site Head Profile:
Reporting to the Biotech Global Quality Leader, with dotted-line reporting to the Site Head, this role is responsible for providing technical, regulatory/compliance, and strategic leadership for the Quality function at their Iowa site. The Quality Site Lead is accountable for all Product Quality, Compliance and Quality System activities as well as for development, launch and commercialization of new products in collaboration with the R&D department and other relevant functions. This role is a core member of the site leadership team who collectively steer the business mission of the site.
Quality Site Head Key Activities
The successful Quality Site Head will be responsible for the following tasks:
- Provide strategic leadership and oversight for Quality Assurance and Compliance initiatives, as well as Quality Control testing facilities, for global product launch, manufacturing, and distribution. As a member of, and collaborating with, the Site Leadership Team, drive continuous improvement through development and execution of a robust Quality Plan.
- Develop the organization to improve technical depth and capabilities related to Biotech products manufacturing. This includes identifying individuals with technical and/or leadership potential for succession planning, or recruiting talent as needed. Will champion the efforts of 5 direct reports and lead an overall Quality organization of roughly 80 personnel.
- Responsible for Strategic planning, direction, and leadership for all GxP training activities at the site.
- Provides leadership and direction to the Operations Unit for implementing quality policies, strategic plans, systems and procedures that will assure purity, efficacy, safety and potency of all products manufactured or tested at the facility. Ensure robust root cause investigations are conducted with appropriate CAPAs to resolve issues that may impact the quality and/or regulatory compliance of manufactured products.
- Provides business partnership to various departments and entities within the broader network such as but not limited to: Sites operating under Establishment 196 licensure, Operations, Technical Services and Manufacturing Science, Marketing, Research and Product Development, Regulatory Affairs; for quality & compliance topics relating to current products, product launch, and for getting the facilities registered /approved for worldwide production/distribution.
- Serves as the leader for regulatory inspections at the site. Ensures compliance with all regulatory requirements relating to product quality and right to operate by implementation of relevant regulatory requirements, as well as education and training of the workforce.
- Responsible for final approval at the site for the following: testing, inspection and release of packaging components, raw materials, labeling, and finished products; product and process validation; quality documentation; and execution of release of products, recalls, market withdrawals.
Quality Site Head Specification
The following will be required of the Quality Site Head:
- 10+ years of experience in pharmaceutical and/or vaccine/Biotech production.
- 5+ years of experience in people management including direct & indirect reports.
- Thorough knowledge of 9CFR (USDA) regulatory requirements for Biotech products, including direct experience with external audits.
Quality Site Head Personal Skills and Qualifications
The successful Quality Site Head will possess the following:
- Bachelor’s degree in biochemistry, chemistry, virology, biology, or science related field; Advanced degree highly preferred
- Versatility in conflict resolution, problem solving and working with cross functional teams.
- Ability to set up partnerships with regulatory authorities and relevant functions to resolve quality & compliance issues.
To Apply for the position of Quality Site Head, 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/