Pipeline Therapeutics, Inc., is seeking a Director/Senior Director of Quality Assurance. The ideal candidate will be responsible for operational management and strategic planning of a spectrum of QA activities, including relevant SOP development, product testing, manufacturing and release, and product distribution. This QA position will be key in the selection of Contract Development Manufacturing Organizations (CDMOs), CROs and other vendors to support clinical development of the company’s programs.
Primary responsibilities include establishment and maintenance of internal QA GxP systems, oversight of CDMOs/CTLs to ensure compliance as well as global regulatory requirements. This QA position will work to continuously improve GxP quality processes and to support the state of GxP compliance at Pipeline Therapeutics. The position will initially focus on GxP Quality build-out to strengthen early-stage Clinical-phase Quality Systems, ensuring that the systems and processes developed will accommodate future late-stage and commercial requirements.
This is an exciting, interdisciplinary role for a highly qualified and motivated individual with expertise in QA management. The company seeks to identify candidates with diverse small molecule drug development backgrounds and the organizational and interpersonal skills required to build strong relationships with internal collaborators.
Responsibilities:
- Independently provide QA oversight of GxP activities at Pipeline Therapeutics and its CROs, CDMOs, CTLs, GMP storage and distribution vendors, as well as on-site auditing of each.
- Develop and implement risk-based Quality strategies for investigational materials including establishment and maintenance of phase-appropriate quality systems; proactively identify and mitigate quality risks.
- Responsible for QA-related activities and requirements to enable release of starting and critical raw materials, drug substance, drug product, and finished goods.
- Ensure CMC, nonclinical and clinical vendor activities are compliant with cGMP, GLP, GCP, FDA, ICH, EMA regulations and guidelines and industry standards.
- Lead strategic development, implementation, and maintenance of Quality Systems and SOPs related to GxP activities.
- Lead QA-related investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with investigations, deviations, product complaints and recalls.
- Collaborate with CMC, nonclinical, clinical and regulatory colleagues to establish metrics and report the state of QA and compliance of GxP vendors to senior management.
- Stay abreast of industry developments – forthcoming regulations, guidance, best practices, as well as training and mentoring staff on global GxP regulations and guidance.
- Ensure routine regulatory inspection readiness to prepare for audits by global regulatory health authorities.
- Strong understanding of GMP Quality for starting/critical raw materials, drug substance, drug product, and label and packaging, including QC testing, stability, and distribution.
- Coordinate safety activities and training for inhouse research lab; including the maintenance of records, the identification of potential deficiencies, the recommendation of corrective actions, and ensuring compliance with regulations.
- Preparation for audits of the company by external or regulatory organizations
Candidate must possess:
- Minimum B.Sc. degree in Life Science field, advanced degree a strong benefit, and a minimum of 15 years of applicable pharmaceutical drug development experience with at least 10 years of Quality Assurance experience.
- Useful background within a fast-paced, innovative, biotech start-up organization could include experience with critical starting materials, materials/reagents and sterile dosage drug products.
- Strong working knowledge of global GxP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct. Direct experience in successfully managing health authority Inspections, multiple projects and responsibilities concurrently.
- Ability to work with multi-disciplinary teams and with individuals at all levels.
- Ability and willingness to travel up to approximately 25% of the time.
Salary Range: $180,000 – $255,000
Please submit your resume or CV and supporting documents to info@pipeline-tx.com.
