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Senior Director, Site Quality Head, Goa

Teva Pharmaceuticals

Parsippany-Troy Hills, NJ

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JOB DETAILS
SKILLS
Alliance/Partner Management, Analysis Skills, Best Practices, Biology, Biotech and Pharmaceutical, Budgeting, Business Processes, Channel Strategies, Chemistry, Coaching, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Management, Data Quality, Drug Manufacturing, Environmental Health, Equal Employment Opportunity (EEO), Equipment Validation, FDA (Food and Drug Administration), Fast Food, GMP (Good Manufacturing Practices), ICH Regulations, Immunology, Laboratory Management, Laboratory Operations, Leadership, Lean Manufacturing, Licensing, Maintain Compliance, Manufacturing, Manufacturing Operations, Market Analysis, Medical Conditions, Medicine, Metrics, Microbiology, Neuroscience, Operational Expenditure (OPEX), Performance Metrics, Pharmacy, Procedure Development, Process Improvement, Product Packaging, Project/Program Management, Quality Assurance, Quality Control, Quality Management, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Validation/Verification, Research & Development (R&D), Resource Utilization, Risk Analysis, Risk Management, Safety Training, Safety/Work Safety, Supply Chain, Supply Chain Management, Testing, Time Management
LOCATION
Parsippany-Troy Hills, NJ
POSTED
13 days ago
**We Are Teva** We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. **The opportunity** Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements. Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices **How you’ll spend your day** + Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations. + Ensure a current Quality Management System is in place and continuously improved + Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications. + Most senior professional and independent decision maker authority on product quality and potential market actions + Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply + Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program. + Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance + Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site + Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality + Maintain strong partnership with site leadership team + Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met + Provide effective Quality leadership during internal, customer and Health Authority inspections + Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically + Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization. **Location** This role is based on the Teva site in Goa, India. **Your experience and qualifications** + Required – bachelor’s degree in chemistry, Biology, Pharmacy + Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy Key Requirements: + Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including: + Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process, + High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types, + Strong understanding and experience in Data Integrity and Compliance + Experience preparing and/ or leading regulatory authority GMP + Deep knowledge of Quality Systems + Proven successful track record of leading organizational change to improve efficiency + Experience leading, inspiring and coaching large teams + Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes + Must have adequate knowledge of Quality best practices + Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control + Must have adequate practical knowledge of analytical techniques and microbiological principles + Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer + Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools + Good knowledge of environmental, health and safety requirements for laboratories and quality operations. **How We’ll Take Care of You ** At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.  **Teva’s Equal Employment Opportunity Commitment** Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva'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. EOE including disability/veteran

About the Company

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Teva Pharmaceuticals