Senior Director, Head of Quality Compliance, Teva api
Who we are
Location of the role
This role is available at our EU HQ in Amsterdam. We will move our office to Haarlem (greater Amsterdam) later this year.
Other locations are Israel, Hungary, Italy, Czech Republic or Croatia.
We are looking for a Senior Director, Quality Compliance Head TAPI. In this role you will lead develop the team of Teva api Quality Compliance. You will ensure Tapi api Divisional Policies (QMS) are maintained and updated and will ensure that each site within Teva api receives the right level of support to maintain and enhance GMP compliance, to solve quality related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to Teva api standards.
How you’ll spend your day
- Lead the TAPI Quality compliance team of highly professional specialists in accordance to TEVAs values and leadership standards
- Maintain the TAPI Quality Management System for APIs in line with the corporate Quality Management System.
- Maintain the Electronic Quality Management Systems (i.e. StarLims, Trackwise, Priority (QA module)
- Ensure together with the Members of the TAPI Leadership team at all Sites within TAPI that the TAPI Quality Management System (QMS) is implemented and the local Quality Management Systems is up to date.
- Responsible for the management of the TAPI Quality Council (scheduling, conduct, recording, follow up) and other meetings as applicable.
Your experience and qualifications
- Degree in Chemistry, Biology, Microbiology, Pharmacy or similar demonstrated knowledge in cGXP regulations.
- 15+ years' experience in GMP environment, continuous professional development 10+ years' experience in managerial tasks, to lead a quality department or organization Exposure to International working environment
- Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation etc.
- Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including FDA, PMDA and Anvisa requirements
- Ability to understand and execute against Teva api Quality Management System
- Knowledge product types and manufacturing operations
- Problem solving and good team work skills
- Proactive orientation, communication skills
- Proven influencing capabilities
- Fluent in English
Coordinates within the Compliance Team the following tasks:
- Ensures the timely availability of data to the reporting portals (e.g. Bl system, etc) and provision of TAPI reports, as but not limited to monthly Highlight Reports, weekly product issue reports, quality related out of stock reports etc.
- Performance management and reporting
- Project management, monitoring, execution and reporting
- Coordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in compliance
- Customer experience management — work with customer experience for general set up of QA and QC requests
- Coordinator Role of the Notifications to Management process within the TAPI and the global Notifications to Management process, both in accordance to global standard including QAM and MAC meetings (numbering, issuing, assessment, follow up, closing, defining market action where applicable). Reporting of a monthly status update. Support of execution and coordination of recalls
- Oversight to the evaluation of effectiveness of the corrective and preventive actions.
- Quality risk assessments Inspection readiness
- Adherence to quality metric definition
- Data integrity governance others as per assignment and sites request
- Establish and monitor governance on data integrity requirements.
- Establish and manage the TAPI Change Control Forum
- Cooperate with other functions within Quality projects and their role out. Act as a quality SME and support global compliance initiatives upon request Participates in audits upon request.
- Fosters knowledge sharing among sites within the TAPI
- Nitrosamine management
VP Quality, API AMSO
Vincent van Straten - Team Lead Recruitment
Already Working @TEVA?
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Pre employment check
Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.