Position Summary
The Clinical Quality Product Lead (CPQL) is responsible for stewardship of clinical product quality from candidate selection through to commercial approval. As the Quality representative on the CMC Team, the CPQL supports clinical product scale ups, accelerations, integrations and partnerships in collaboration with cross functional stakeholders including CMC, Analytical Sciences, Product Technical Leads and Regulatory Affairs.
The CPQL builds strategies to ensure compliant on time release of FIH (first in human) product, acting as the product quality Subject Matter Expert (SME) for cross functional GMP quality deliverables. Following FIH trials, the CPQL oversees the quality activities to scale up and supports early and late-stage clinical programs.
Principal Responsibilities
- Provides quality oversight for several clinical products (including small molecule, VHH antibody, mAb, oligo, peptides and genomics) across various presentations (ex. vial, prefilled syringe, autoinjector, tablet, capsule) from pre-clinical up to commercial launch.
- Acts as Quality advocate and SPOC for CMC program strategy teams to ensure a consistent quality approach and deliverable completion for GMP manufacturing, testing, release, and regulatory filings.
- Proactively manages clinical product quality risks ensuring they are assessed, mitigated, and communicated to Senior Management.
- Serves as Quality Assurance support and SME for clinical manufacturing, maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, testing, storage and shipping activities are compliant and appropriate to product phase.
- Chairs Quality Subteam to ensure Operations Quality, External Quality and QP are aligned on timelines, aware of risks and prepared for oversight of product quality post launch (product release and clinical supply timelines, quality systems).
- Establishes the release strategy for new products in partnership with Qualified Persons (QPs).
- Reviews and assesses significant product related deviations, including risk assessments, root cause analysis, investigation, and reporting.
- Facilitates change controls impacting clinical products.
- Supports CMO selection, onboarding, audits and inspections, as well as management and negotiation of quality agreements.
- Quality SME for regulatory submissions, including IMPD & IND, and responses to regulatory agencies.
- Responsible for supply chain maps and product specification file summary documents.
- Supports integration of acquired assets via business development.
Qualifications & Experience
- 8 years+ experience within cGMP quality assurance in a biotech, pharmaceutical or biopharmaceutical manufacturing environment, including 5 years + experience working in the pre-clinical through commercial phases.
- Experience with review of market applications, INDs, supplements, and similar regulatory documentation
- Experience working with contract manufacturing and laboratory organisations.
- Understanding of pharmaceutical drug product development and manufacturing.
- Knowledge of quality systems, including product release (Annex 16) and quality control.
- Ability to make decisions, solve problems, and manage ambiguity.
- Ability to collaborate, negotiate, influence and lead in a matrix organisation.
- Excellent verbal and written communication skills.
Preferred Qualifications
- Prior experience with genomic medicines.
Education
- BSc. degree in biological / chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry
Date Posted
04-Mar-2024
Closing Date
29-Apr-2024
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