Teva Pharmaceuticals Associate Director Global Quality Computer Systems, Laboratory Systems in Parsippany, New Jersey
Associate Director Global Quality Computer Systems, Laboratory Systems
Date: Nov 12, 2021
Location: Parsippany, New Jersey, US, 07054
Company: Teva Pharmaceuticals
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed toimproving health and increasing access to quality health solutions worldwide. Our employees are at the core ofour success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 millionpeople every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built apromising pipeline centered around our core therapeutic areas. We are continually developing patient-centricsolutions and significantly growing both our generic and specialty medicines business through investment inresearch and development, marketing, business development and innovation. This is how we improve health andenable people to live better, healthier lives. Join us on our journey of growth!
We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting onthe first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee StockPurchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com
This role will have oversight and accountability responsibilities for the global QC Laboratory Computer Systems (LIMS, Empower) as the Global Business Owner, including the following:
Setting strategy and defining business priorities for global system deployments based on regulatory commitments and internal Teva initiatives.
Developing and implementing global, harmonization guidances and templates to enhance use of the systems and improve corporate-wide compliance.
Directing business activities, ranging from data and process mapping and requirement gathering to performance qualifications and site acceptance, in support of computer system deployments.
General duties and responsibilities:
Serve as the Global System Business Owner for LIMS, Empower, and other Global Quality computer systems as assigned.
Manage defined implementation of schedules/activities related to program-level project planning and strategy, site implementations, system enhancements, and global roadmap planning
Manage global and site communications, business prioritization, and issue resolution related to computer system deployments and enhancement releases to Teva sites/functions.
Ensure local deployments are aligned with global processes and standards
Act as the Global Business Owner for system validation (review/approval of system requirements and other validation documentation). This activity requires knowledge of computer system validation deliverable requirements and ability to translate the operational needs of the business to the technical computer system requirements.
Participate in system change request/release review and prioritization meetings with counterparts in Information Technology (IT), Compliance, sites, and other internal Teva functions as a Quality Global Business Owner.
Provide program status in Quality Global/regional/leadership meetings
Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field
7+ years in pharmaceutical industry or related industry
Four or more years direct experience with LIMS and/or laboratory data capture software is required
In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
Knowledge of cGxP requirements and Quality related IT applications
Experience with computer system validation
Demonstrated experience with roadmap planning and managing complex projects
Experience in project and/or program management leading cross-functional teams
Experience in regional and/or global role preferred
Must be able to effectively communicate both internal and external to Teva; verbal and written communication excellence required
Must be able to obtain the internal collaboration/input of Teva colleagues, establishing and maintaining sound professional relationships at all levels within the organization
Ability to develop processes and direct project activities
Technical knowledge and expertise with QC laboratory computer systems and processes
Demonstrates resourcefulness and initiative and creates an appropriate level of urgency to meet objectives and deadlines
Director, Global Quality Compliance
Already Working @TEVA?
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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