Oversees comprehensive and GMP compliant Quality Leadership across the end to end product lifecycle and integrated supply chain for Shire’s product portfolio. Interfaces with and provides guidance to cross functional stakeholders on matters pertaining to Quality and to other Quality organizations on matters pertaining to product/process.
Influences and executes Tech Ops product strategy including, new product development and launch, acquisition integration, partnership management, risk management, regulatory strategy, global expansion and supply continuity.
Executes product quality governance and Quality technical knowledge programs for all Shire products and associated combination products. Drives product improvement and sustainable compliance to ensure robust development, manufacturing, testing, and product review. Provides technical input to incidents investigations and change controls and owns product specifications. Assesses product quality performance to demonstrate levels of control, capability and compliance of Shire’s products and inform sound quality batch decision making, strategic product life cycle decisions and effective Health Authority dossiers in support of Shire’s existing commercial (In Line) and pipeline products and product candidates.
35%: Assures adequate PQL support across the end to end lifecycle and integrated supply chain for all products compliant with all GMP, SOP, clinical, device, and regulatory requirements. Accountable for product specification, leads significant cross site investigations and provides Technical Quality expertise for incident escalations. Ensures appropriate risk and criticality analysis is performed and control strategies are developed. Provides guidance to other Quality organizations on matters pertaining to product/process. Provides weekly product updates to Senior Management.
35%: Ensures Quality representation for cross functional CMC and new product launch, due diligence and integration activities and Technical Operations Teams to Inline and Pipeline committees. Interfaces with Process Development and Technical Service and Product Operations & Network Excellence organizations to influence product and regulatory strategy, due diligence and integration activities, to gain knowledge and share with Quality organization. Ensures Quality receives process/product technical training. Provides direction to the PQL team to ensure that the organization is staffed with personnel with the correct balance of experience, knowledge and competencies.
25%: Influences strategy to enhance and executes the following programs to acquire, manage and use product and process knowledge globally: Quality Review and approvals of Regulatory submissions, quality by design, continual process verification, due diligence and integration, partnership management, divestment and discontinuation, PQR review and approvals and real time product performance, product quality risk register.
5%: Participates as member on the Quality Systems and Product Quality Leadership Team to manage and oversee all aspects of the organization’s performance including Human Resource development, technical performance, ongoing Quality initiatives and Operational Excellence.
Education & Experience Requirements
Essential: Bachelor’s Degree in a technical discipline such as biochemistry, chemistry, engineering and at least fifteen years of experience in the biotechnology and/or pharmaceutical industry; experience with plasma /large molecule production processes, aseptic processing,; experience in quantitative analytics; experience running a clinical or commercial quality assurance team; proven people manager and leader capable of developing people and teams with at least ten years of management experience; experience leading, training and/or implementing, assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; practical manufacturing/packaging environment experience; understanding of GMP’s within a global environment; understanding of GDPs and global supply and distribution networks.
Desired: Advanced Degree
Domestic and international travel up to 25% for business meetings with local staff, corporate peers/collaborators, Contract Manufacturing Operators and to stay current with professional development opportunities.
Location/Region: Lexington, MA