Director Quality Control

## 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.
## Our Team, Your Impact

This Director of Quality Control is responsible for overseeing QC testing for Chemistry and Microbiology functions for raw materials, in process, and finished product at the Davie and Sunrise sites. It includes release testing, stability testing or analytical support testing to R&D site and/or contract partners to support new product introductions and quality improvement initiatives. Review and approve analytical documents for experimental and submission batches.  Interpret and assure that all cGMP and applicable regulations are followed while anticipate and satisfy internal and external customer requirements to robust laboratory procedures and technologies.

The position provides strategic leadership for laboratory operations, compliance, modernization, and continuous improvement initiatives. This role is responsible for driving digital transformation, automation, and innovative quality solutions that enhance regulatory compliance, operational performance, data integrity, and organizational effectiveness while supporting the site's long-term business objectives.

## How You’ll Spend Your Day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation, if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

- Support the implementation and maintenance of sample management, stability testing program, and general laboratory operational systems in accordance to cGMP requirements.
- Manage a team of QC laboratory professionals and oversee performance management, mentoring, and career development.
- Collaborate closely with our network of QC laboratories, internally and externally, around the globe and partner with onsite Supply Chain, Project Management, R&D, and Commercial to ensure project deadlines and objectives are met
- Provide knowledge to the development, implementation, and maintenance of QC Analytical Chemistry and Microbiology.
- Support sites in regulatory and third party inspections, and provide technical support for specification and method development, laboratory equipment troubleshooting, and laboratory OOT and OOS investigations.
- Advise management on U.S. and foreign regulatory requirements and serve as liaison with FDA and other regulatory agencies. Conduct all activities toward qualification and maintenance of QC activities and ISO registration.
- Assist in the development of a company-wide LIMS system. Optimize workflow by eliminating manually written QC records, maximize the use of the LIMS system, and support reduce testing initiatives.
- Connect to Analytical Research teams (e.g. Weston Florida) for the early transfer and/or validation of analytical methods of the new products assuring the process for the knowledge transfer to Florida commercial laboratories team to properly implement the new methodology for the validation campaigns.
- Support Florida sites in regulatory and third party inspections, and provide technical support for specification and method development.
- Provide technical expertise during the troubleshooting related to laboratory OOT and OOS investigations. Review and approve laboratory OOS investigations and sponsor the completion of concerning CAPAs to avoid investigation reoccurrences of laboratory related errors.
- Lead the development and execution of QC Rough Cut Capacity Planning (RCCP) processes to ensure adequate laboratory resources, testing capacity, instrumentation availability, and staffing levels are aligned with production requirements and business priorities.
- Act as a strategic Quality Control partner to Supply Chain and Manufacturing organizations to ensure testing activities support production schedules, inventory targets and customer service levels,
- Mentor QC group leaders and other QC resources direct reports to prepare a weekly schedule and tracks work flow for appropriate group(s). This includes making fair judgements aligned to the business needs to switch/change schedules due to priorities or needs of the Company.
- Ensure analytical/microbiological procedures and specifications are developed, validated, and implemented for laboratory testing in a manner consistent with Corporate and Divisional Policies and any modifications are supported by appropriate scientifically sound data.

## Your Skills and Experience

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

- Bachelor's Degree in Pharmaceutical Sciences, General Science (Chemistry, Microbiology, Biology and Biochemistry) or Chemical Engineering.
- Master degree or PHD degree in aforementioned  disciplines are preferred.
- At least 12 years of pharmaceutical industry experience under CGMP practices, FDA, and other regulatory requirements, with at least 8 years of experience within a laboratory environment
- Exposed to Lean Manufacturing, Six Sigma or OpEx Tools for area transformation projects
- Experience in leading laboratory projects, leading focus teams and managing others
- Experience implementing laboratory automation, digital workflow solutions, advanced analytics, and enterprise laboratory systems.
- Proven ability to lead complex cross-functional transformation projects and deliver measurable improvements in compliance, efficiency, testing-cycle time, and right-first-time performance

## Also Good to Have

Additional areas of resonsibility

- Lead the strategic modernization of Quality Control operations through the implementation of automation, digital technologies, and innovative laboratory solutions that enhance compliance, efficiency, productivity, and data integrity.
- Drive the evaluation, selection, deployment, and lifecycle management of laboratory automation platforms, digital quality systems, advanced analytics tools, and emerging technologies to improve laboratory performance and decision-making.
- Sponsor and govern automation and digital improvement projects, ensuring realization of business benefits, sustainability of implemented solutions, and achievement of key performance indicators.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.
- Enforce safety and cGMP polices within the Quality Control laboratory.
- Review, evaluate and approve PPQ protocols, Technology Transfer protocols, Stability protocols assuring the analytical responsibilities are clearly established using qualified equipment and validated methods.
- Participate actively in regulatory inspections (FDA, DEA, Department of Health, etc.).
- Accountable for the information required to prepare laboratory budget and administers laboratory operations to maintain expenses, within approved budget.
- Prompt and encourage QC resources for continuous innovation and improvements using OpEx tools and Teva Lean Management System (TLMS).
- Lead the implementation and sustainment of Lean Laboratory principles to improve laboratory efficiency, reduce waste, optimize workflows, shorten testing cycle times, and increase productivity while maintaining compliance and data integrity.
- Develop and execute the laboratory digitalization strategy, leveraging advanced laboratory technologies, LIMS, electronic workflows, laboratory automation, data analytics, and digital reporting tools to improve operational performance and compliance.
- Accountable for identifying and implementing strategies to reduce Quality Control operating expenses through process optimization, laboratory automation, efficiency improvements, vendor management, and resource optimization

## 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.

We offer a competitive benefits package, including:
•    Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. 
•    Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. 
•    Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays. 
•    Life and Disability Protection: Company paid Life and Disability insurance. 
•    Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

## Already Working @Teva?
Make sure to apply through our internal career site on Twist—your one-stop shop for career development
## 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.

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. Request a reasonable accommodation by sending an email to [email protected] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.

Important notice to Employment Agencies - Please Read Carefully

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.