Director Quality Function

Teva Pharmaceuticals; Town of Florida (NY); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Paid time off

Flexible working arrangements

Job summary

Teva Pharmaceuticals seeks a Director of Quality Compliance to lead the site's compliance strategy, QMS governance, and inspection readiness across the organization. You will drive data-driven risk monitoring, implement TLMS and OpEx practices, and partner with multiple departments to ensure product quality and patient safety.

The role emphasizes strategic leadership, cross-functional collaboration, and proactive risk mitigation to sustain regulatory performance and operational excellence at the

Qualifications

• Bachelor in Science or Engineering or related field; 10+ years pharma experience.
• 6+ years in a managerial capacity within the pharmaceutical industry.
• Experience with QMS, regulatory inspections, and quality governance.

Responsibilities

• Lead regulatory audits and inspection readiness across sites.
• Oversee supplier qualification and cGMP audits for excipients and contractors.
• Drive QMS governance, digital quality platforms, and predictive analytics for risk monitoring.
• Collaborate with cross-functional partners to translate analytics into remediation plans.
• Lead the site quality council and CAPA programs; ensure regulatory compliance.

Skills

Regulatory audits

Audit readiness

Data analytics

Communication

Project management

Policy interpretation

Education

Bachelor's degree in Science/Engineering or related field

10+ years pharma experience

6+ years managerial experience

Job description

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

The Director of Quality Compliance provides leadership for the site's compliance strategy, Quality Management System (QMS) governance, regulatory inspection readiness programs, and deployment of new quality technologies and digital platforms. The position is responsible for fostering a strong culture of quality, data integrity, risk-based decision making, and compliance excellence while driving sustainable improvements in operational performance and regulatory outcomes. This role leverages advanced data analytics, predictive compliance risk monitoring, Teva Lean Management System (TLMS) principles, and Operational Excellence (OpEx) methodologies to proactively identify, assess, and mitigate quality and compliance risks before they impact regulatory performance, product quality, or patient safety.

This position serves as a strategic enterprise leader responsible for developing, implementing, and advancing Quality Compliance programs that ensure sustained regulatory compliance, inspection readiness, operational excellence, and product quality across the organization.

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.

• Manages Regulatory Authority and other external compliance audits (e.g. Third Party audits), including communication and tracking of observations and associated responses.

• Oversees the resolution of issues found during audits/inspections in conjunction with the Quality Assurance, Manufacturing, Packaging, Regulatory Affairs, Supply Chain, etc. functions.

• Oversee the Supplier Qualification program for the site, and external current Good Manufacturing Practice (cGMP) audits for excipient vendors, service providers, and contractors used by the sites. Ensures vendors are re-qualified based on established re-qualification frequencies. Liaises with the Corporate Auditing Group to ensure global vendor audits are performed in a timely manner to meet site vendor qualification requirements.

• Provide strategic oversight of the site Nitrosamines risk management program including risk assessments, control strategies aligned with Teva Global Nitrosamines Strategy and applicable regulations.

• Leads the Inspection Readiness Program for the Davie site.

• As part of Inspection Readiness, assesses the regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes a review of major/critical observations from other Teva sites and pharmaceutical companies, and implementation of site CAPAs, as appropriate.

• Hosts Inspection Readiness meetings with a site cross-functional team to identify and plan remediation activities/projects related to potential compliance issues.

• Evaluates all Critical Quality Global Notifications to Management (GNTM) to determine potential impact to the Davie and Sunrise sites.

• Ensures the filing of Field Alerts and Notification to Management (NTMs) for critical agency reportable events.

• Leads site quality council meetings

• Researches new and developing trends in cGMPs and serves as a compliance information resource.

• Leads the use of approved Artificial Intelligence (AI) and advanced data analytics, where appropriate, to identify, trend, and predict potential compliance risks across site quality systems, including audits, inspections, CAPA, deviations, complaints, supplier quality, and inspection readiness activities.

• Partners with Quality, Manufacturing, Packaging, Regulatory Affairs, Supply Chain, IT, and other cross-functional stakeholders to define compliance risk indicators, monitor emerging risk signals, and translate predictive analytics outputs into risk-based remediation plans and Quality Council discussions.

• Drives continuous improvement of compliance risk monitoring by evaluating analytics trends, escalating significant risk signals, and recommending proactive CAPAs, inspection readiness actions, or management notifications as appropriate.

• Leads the strategy, governance, implementation, and continuous improvement of Quality Management System (QMS) processes and digital quality platforms to ensure regulatory compliance, operational effectiveness, data integrity, and alignment with business objectives.

• Oversees, participates and approves the interviewing, hiring, and training, of departmental employees; conducts performance evaluations for direct reports; and assists direct report supervisors with performance evaluation process for their units.

• Provides support, direction, and coaching to subordinate employees in the areas of disciplinary action, problem resolution, planning, and work assignment delegation.

• Ensures project deadlines and performance standards are established and met.

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:

• Requires Bachelor Degree in Science, Engineering or related field from an accredited college or university, with a minimum of 10 years of relevant progressive experience in the pharmaceutical industry, including 6 years in a managerial capacity.

Also Good to Have

Additional areas of responsibility

• 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 (cGMPs), and Standard Operating Procedures (SOPs) instructions.

• Responsible for performing additional related duties as assigned.

Skills/Knowledge/Abilities:

• Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.

• Creating, planning, and implementing goals, objectives, and practices for effective, efficient and cost effective management of allocation resources.

• QMS implementation and lifecycle management

• Predictive risk modeling and trend analysis

• Responding to technical inquiries from management, employees, and regulatory agencies.

• Communicating clearly and concisely, both, orally and in writing.

• Ability to communicate effectively with senior management.

• Managing multiple projects, duties, and assignments.

• Interpreting and applying Federal, state, and local policies, procedures and regulations.

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.

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