Sr Director, Global IT Quality Compliance
Parsippany, United States, New Jersey, 07054
Who we are
The opportunity
This role is part of the global Quality Compliance leadership team guiding CSV Quality Compliance within Teva. Within this role, the leader establishes and maintains effective working relationships with peers within the Global Quality Compliance organization, Teva Global Operations Compliance segments, IT TGO Quality and Compliance and executive stakeholders in both the Quality and IT organizations. The Computerized Systems Governance organization provides oversight and monitoring to ensure that teams delivering and maintaining GxP computerized systems are doing so in accordance with Teva policy, standards and procedures.
The Senior Director IT Quality Compliance leads the organization to ensure computerized systems used in support of GxP processes are effective and managed in compliance with current regulations. This position is accountable to ensure the Teva QMS for Computerized System Validation (CSV) used in the delivery of GxP computerized systems is in alignment with current regulations, Data Integrity principles, industry guidance and inspection trends. This leader manages the global Computerized Systems Governance team that maintains CSV governance, regulatory oversight of the IT organization, inspection and audit support to Teva’s sites and ensures consistent inspection readiness is maintained at all times.
Location: This is a hybrid role that can sit out of our Parsippany, NJ or West Chester, PA offices.
How you’ll spend your day
- Accountable for developing the compliance strategy, short- and long-range plans for the Global Computerized Systems Governance organization
- Liaise with TGO Global Quality, site, IT and business stakeholders
- Continuously improve the policy, standards, procedures, tools and training related to cGxP CSV ensuring alignment with regulations (Eudralex Annex-11 and 21 CFR Part-11), industry guidance, inspection trends and current Data Integrity guidance
- Fulfill the role of CSV/Data Integrity subject matter expert and ensure current best practices are exercised in support of global GxP computerized systems
- Institute and deliver monitoring program measuring adherence to current CSV practices within the global IT organization
- Provide site and global resources with CSV and DI consultation to supplant skill gaps
- Provide on-site CSV inspection readiness support before and during regulatory inspections
- Deliver training programs for IT, Quality and site-based resources to improve CSV skills, provide education related to inspection trends and generate awareness of the importance of CSV and Data Integrity
- Architect, govern and manage IT infrastructure qualification aligned with current industry regulations, inspection trends, best practices and guidance
- Ensure Data Privacy regulations are incorporated into the Computerized System landscape
- Provide business ownership of IT based GxP computerized system tools such as IT change management, test management, identity management etc.
- Responsible for computerized system quality for the serialization and aggregation programs
- Afford CSV Quality subject matter expertise and consultative services to the various Teva business segments such as Commercial, TGO, R&D, Clinical and Teva API etc.
Your experience and qualifications
Qualifications
- Bachelor’s degree in computer science, science or related field (advanced degree a plus)
- Minimum 15 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing and laboratory operations
- Prior experience managing direct and matrix teams/projects is required.
- Demonstrated leader in CSV governance
- Strong understanding of regulations and industry standards such as 21 CFR Part-11, Eudralex Annex-11, GAMP 5, Data Integrity regulatory and industry Guidance and proven ability to pragmatically apply these regulations to operate in an efficient and effective fashion.
- Must have international experience
Practical Knowledge and Experience
- Pharmaceutical Quality Manufacturing: Solids, Medical Device, Sterile, Biologics, and/or Biosimilars Quality Compliance experience required.
- Demonstrates continuous professional development.
- Advanced leadership skills, business strategy, accounatbility, proven experience leading leading and motivating global, cross-functional teams.
- Advanced knowledge of local current and upcoming legislation and current IT Quality Compliance best practices.
- Advanced experience in working with matrix environment.
- Advanced negotiation skills.
- Advanced knowledge and experience in Problem Solving
- Advanced ability to understand, interpret, and execute in accordance the Teva Quality Management System.
- Advanced communication skills – written and verbal
- Advanced organization and political agility leadership and teamwork skills
- Project management certification (e.g. PMP) is a plus.
- Must be able to travel based on business need; up to 50% when critically required (domestic and international).
Professional competencies :
- Energetic, committed to continuous improvement. Effective negotiation skills, strong interpersonal skills, excellent presentation skills. Strong project and change management. Proactive orientation, self-motivated, flexible, and innovative way of thinking*.
- Ability to work with various organizational leadership levels and in a team environment across multiple roles. Multi and Intercultural sensibility*
- Languages: English Proficiency*. Proficiency in the local language
Business Excellence:
- Building Customer Focus
- Addresses multiple site issues in a timely manner.
- Effectively adjusts plans to meet changing needs of priorities.
- Applying a Strategic Approach
- Makes the right short-term decisions without sacrificing long-term results.
- Integrates input from different areas together and balances all competing demands based on wide and long-term understanding on the business needs.
- Applying Business Acumen
- Holds a broad perspective and understanding of processes and translates this understanding into Quality terms (and vice versa). Translates business & industry trends and regulatory standards into business imperatives.
- Applies knowledge of industry's best practices to provide inputs for increasing operational productivity within assigned area of work.
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
If you are a current Teva 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 Teva 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.
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.
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
