Product Quality Lead
Proclinical has partnered with a leading pharmaceutical company in search for a Product Quality Lead. You will be a representative for a Global Product Team, accountable for consulting and informing stakeholders of relevant quality information.
- Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers
- Support quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the operational strategy, GMP requirements and are verified for accuracy and data integrity.
- Represent Product Quality program in CMC meetings with global regulatory agencies and during regulatory inspections
- Represent Quality in Global CMC and Commercialization teams
- Quality lead supporting business growth in product launch, due diligence, divestment and integration activities and works in partnership with relevant stakeholders to influence quality, supply and regulatory strategy.
- Lead product quality related cross-functional teams
- Maintain oversight of product performance and develop countermeasures via strategic and tactical quality input to develop sustainable compliant product with continuity of supply.
- Supports the Incident Escalation process.
- Support the definition of product critical quality attributes, deliver and drive control strategy, deliver phase-appropriate product specifications.
- Provide quality oversight and guidance during product launch
- Provide strategic guidance in support of the timely implementation of multi-site global changes with regulatory impact
- Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase
- For development products, develops product knowledge repositories and utilises product expertise to support the product throughout lifecycle. Supporting Risk Management program and owner of corresponding actions.
- Support the establishment of preferred Supply Chain architecture. In collaboration with relevant stakeholder's, develops recommendations which improve product, process and
- Supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those product nearing commercialization
Skills and Requirements
- Science or Technology degree in a relevant discipline
- Minimum 7 years Biopharmaceutical or Life Sciences industry experience
- Strong knowledge of GMP & GDP regulations, FDA 21 CFR, EU GMP and ICH Guidelines
- Experience managing supplier audits, quality agreements, change notifications, deviations and CAPA management
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.