Sr. Manager, Microbiology Quality Compliance Expert

Who we are

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With
the industry's broadest portfolio including over 350 API products, TAPI is the go-to global
supplier for APIs, supporting 75% of the top 50 global pharmaceutical companies.
Headquartered in Israel, TAPI employs more than 4,000 professionals at 13 sites worldwide.
We provide superior product quality and excellent customer service.

The opportunity

We are looking for a Sr Manager, Microbiology-Quality Compliance Expert - TAPI. 
The main purpose of your job will be to ensure that the Microbiology laboratories, systems , procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.  
 
This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.

How you’ll spend your day

•    Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areas
•    Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)
•    End to End Support for Health Authority Inspections  focused on Microbiological aspects
•    Support the Implementation of Quality Risk Management
•    Review and Monitor Quality Improvement Plans
•    Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard System
•    Support Global Quality Compliance Initiatives eg; Cross contamination strategies
•    Data Reliability assessments, gap evaluations, GxP data mapping in the micro labs
•    Review global TAPI policies and standards and provide inputs
•    Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc)

Coordinates within the Compliance Team the following tasks:

•    Establish and monitor governance on data integrity requirements.
•    Cooperate with other functions on Quality projects and their role out. 
•    Act as a quality SME and support global compliance initiatives upon request
•    Participate in audits upon request.
•    Fosters knowledge sharing among sites within the TAPI

Your experience and qualifications

•    Degree in Industrial Microbiology and demonstrated knowledge in cGXP regulations.
•    10+ years' experience in GMP environment, continuous professional development 5+ years' experience in Microbiology laboratory, managerial tasks, organization Exposure to International working environment
•    Mix of experience in Micro, Quality systems would be preferred.
•    Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, etc.
•    Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirements 
•    Performance management and reporting
•    Project management, monitoring, execution and reporting
•    Problem solving and good team work skills
•    Proactive orientation, communication skills
•    Proven influencing capabilities
•    Fluent in English

Pre employment check

TAPI 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.

Already Working @TAPI?

If you are a current TAPI employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to TAPI employees. Use the following link to search and apply:  Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

TAPI's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is TAPI's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.