Head of Quality Control - Oncology and External Supply Small Molecule, European Region応募 後で応募 求人ID R0011464 掲載日 09/11/2019 Location:Singen (Hohentwiel), Germany; Zurich, Switzerland
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head Of Quality Control – Oncology and External Supply Small Molecule Lead in our Switzerland office.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Head of Quality Control – Oncology and External Supply Small Molecule you will be working on the Quality Control team, you will be empowered meet the Quality and Operating Units vision and objectives, establish priorities, build a regional patient-centred best in class organisation, develop diverse talent and elevate organisational performance, execute on Quality Improvement projects and where appropriate, manage the finances of the team. A typical day will include:
- Establish strong relationships with stakeholders including ESQL, Contract Manufacturing Organisations (CMOs) and Takeda Local Operating Companies. This position interacts with External Supply Quality Lead (ESQL), External Site Leads, Supply Planning, Artwork and other internal stakeholders, as well as Europe based Contract Manufacturers/ Suppliers.
- Responsible for establishing the strategic compliance direction and management of analytical release/stability activities. Activities include but are not limited to data review, tracking and trending, authoring of stability protocols and reports, supporting regulatory submissions, managing contract service providers and coordinating study executions, performing and/or providing audit support.
- Support the assessment of methods, specifications, stability protocols, development reports, analytical validations, analytical transfers, statistical packages, expiry extensions, analytical reports and the assessment of critical analytical changes or deviations, as needed to assure compliance to Takeda standards, regulatory requirements and GMPs.
- Responsible for associated Quality Control budget supporting the Oncology & External Supply Small Molecule (OncESSM) Takeda commercial stability program, providing detailed forecasts and assessments of spend.
- Supports the laboratory investigations and assesses risks for non-conforming product or operations, develops appropriate action plans, including system correction or improvement of operations to minimise future risks for commercial products.
- Subject Matter Expert supporting External Supply Quality Lead (ESQL) teams on testing strategies for new or existing products to ensure GMP and Takeda expectations are met. Ensures the establishment of remediation plans if needed to improve analytical testing strategies.
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline, and minimum of 12 years of QA/QC experience in the pharmaceutical industry, and/or QA/QC laboratory environment.
- Preferably 2+ years’ experience in preparing Chemistry, Manufacturing and Control (CMC) documentation related to pharmaceutical analysis.
- At least 6 years of people management experience desired.
- Broad understanding of Global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of GMP, ICH, and other relevant regulations.
- Knowledgeable in the application of compendia requirements and procedures to testing of pharmaceutical products.
- Fluent in English language oral/written communication skills.
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values- led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People toShine
Discover more at takedajobs.com