Product Quality Lead, Small Molecules and Oncology – Dublin, Ireland – 6 Month Contract
Nicholas Howard are delighted to be recruiting for a new and exciting role as a Product Quality Lead, Small Molecules and Oncology.
Based in Dublin, the PQL – Small Molecules and Oncology, will provide global quality oversight of products, across the assigned product technology platform, from late clinical development phase through commercialisation and throughout lifecycle. They will be part of a team of Product Quality Leads, and be involved in development of strategy to proactively minimise product quality risks during product development, technology transfer, and commercial operations. The PQL is the quality liaison between Regulatory Affairs and Operations to ensure compliance of GMP operations in support of assigned programs. The role enables efficient communication and decision making related to the quality aspects across the Global Product Teams, manufacturing sites and global functions. They are the designated accountable representative for decision making at a strategic level, in consultation with business partners.
This role is accountable for leading a team with the following responsibilities:
- Empowered quality representative for Global Product Teams, translating the global commercial strategy into operational strategy, for execution by the relevant Business Units. Accountable for consulting and informing all relevant quality stakeholders to ensure aligned, strategic decision making.
- Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterisation, 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 Commercialisation 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 organisation 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 commercialisation.
- Responsibility for APQR review and approval and Global APQR summary generation.
Education & Skills:
- BSc. / BEng. or equivalent essential, MSc./Eng. preferred, business related post graduate education an advantage.
- Minimum 8 – 10years experience across a range of quality, technical operations or regulatory functions preferred. Experience operating at global level essential.
- Operational experience as a licensed QP desirable.
- Leadership experience of managing globally located teams highly desirable.
- Subject Matter Expertise in one product platform (Biologics, Plasma or Small Molecule).
- Ability to work autonomously, and an understanding of when to consult / inform / escalate.
- Strong relationship building skills and ability to work in partnership cross functionally with global stakeholders.
- Business alignment acumen with ability to understand commercial strategy and financial literacy.
To be considered for this position please apply below.