The Supervisor/Manager, Quality Assurance (QA) will have significant experience with good manufacturing practices (GMPs), good clinical practices (GCPs) and good laboratory practices (GLPs), as well as a thorough understanding of FDA Quality-related standards/guidance. This experience and expertise will span the entire product development process from preclinical phases through to commercial introduction. The Supervisor/Manager, QA will establish, and maintain quality assurance programs, policies, processes, procedures and controls to ensure that the performance and quality of products, the conduct of clinical trial materials (CTM) manufacturing, and the pre-clinical GLP testing conform to established quality standards and agency guidelines. This position will establish an internal and external (e.g., suppliers/vendors) auditing program to ensure compliance, including GCP auditing of high enrolling clinical centers participating in Soligenix-sponsored programs. He/she will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. This role will represent QA on project teams and will prepare and manage quality agreements between the company and key vendors/suppliers.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance, and may be required to serve as liaison between the company and the various governmental agencies during site inspections.
- Provides expertise to Research and Development (R&D) entities to ensure that the products under development meet appropriate guidelines and FDA expectations and ensure that vendors are qualified appropriately based on the developmental phase.
- Provides oversight of quality programs in R&D organizations to ensure GMP, GCP and GLP compliance including leading the company’s Compliance Team.
- Provides quality oversight to the following areas: Pharmaceutical Development, Supplies Management, Pre-clinical GLP studies and CMO/CRO/vendor selection and qualification.
- Leads corporate technical change control process to ensure key GMP documents such as product specifications and analytical methods are appropriately controlled.
- Establishes and maintains R&D Quality Assurance GLP and GMP programs by: Ensuring R&D QA GLP and GMP SOPs and procedures are kept current; Conducting and managing audits of CROs and contractors per audit schedule; Ensuring Clinical Trial Materials (CTMs) are properly manufactured and released; Ensuring pre-clinical GLP studies are compliant with GLP regulations.
- Establishes key checkpoints for new products and processes. Additional responsibilities include developing a process by which the applications for new drugs (NDAs) meet quality standards and current regulations; supporting the R&D project teams and, reviewing CMC Sections for INDs, NDAs and BLAs; executing and/or managing mock pre-approval inspections (PAIs) for Regulatory Submission support.
- Maintains an active audit program with all vendors and performs audits as needed.
- Maintains up to date Approved Supplier/Vendor list as well as internal and external auditing schedules.
- Leads audits/quality control verifications of key clinical/regulatory documents including IND and clinical trial applications submissions (as needed), clinical study reports, Investigator’s Brochure, etc.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum of BA/BS degree in Life Sciences/Chemistry, PhD Preferred
YEARS OF EXPERIENCE:
- At least 6 years of experience in a Quality Assurance role in the pharmaceutical industry of which 4 years must have been specifically focused on R&D QA compliance activities.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- An advanced attention to detail and excellent written communications skills are a must.
- Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups.
- Ability to communicate with technical and non-technical colleagues.
- Knowledge/awareness of FDA, EU GMP, GLP, ICH regulations and industry best practices.
- Knowledge/awareness of cGMPs, GCPs and/or GLPs and ICH Guidance.
- Deep understanding of the pharmaceutical industry with solid working foundation within the regulatory environment, organization, and structure.
- Knowledge of records and data management; best practices, tools and technology support systems.
- Experience with biologics and vaccines a plus.
- 30% travel anticipated.
How to Apply
Please provide resume, references, and current location via e-mail to firstname.lastname@example.org. Compensation will be commensurate with experience. No phone calls, please. No recruiters.