US Quality Lead, External Manufacturing

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.  We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

As the US Quality Lead, External Manufacturing, you'll report directly to the Senior Manager, Quality. In this pivotal role as an individual contributor, you will take charge of the US pharmaceutical external manufacturing portfolio, spearheading External Manufacturing Quality initiatives, driving impactful decisions, and influencing positive change. Your leadership will be instrumental in overseeing GMP activities, performing gap assessments and updating of Quality documents, managing product portfolios, and fostering a culture of quality excellence within our fast-paced and dynamic environment.

This is a hybrid position with three days in office in Bridgewater, NJ. 

Your Role:

• Product Portfolio Management: Lead the charge in managing our external manufacturing product portfolio, ensuring top-notch GMP activities through collaboration with cross-functional teams.

• Quality Oversight: Dive deep into laboratory, stability, product, and process investigations, guiding effective CAPAs from root cause analyses to conclusive actions.

• Leadership in FAR Assessments: Conduct FAR assessments, lead critical action committee meetings, and ensure escalation and technical reviews.

• Continuous Improvement: Drive constant improvement in our Quality Management Systems (QMS), maintaining audit readiness and fostering a culture of excellence.

Your Qualifications & Experience:

• 8+ years of quality experience in pharmaceuticals or combination products, demonstrating competence in investigations, Change Controls, and CAPA management in a regulated environment.

• Bachelor of Science in Pharmaceutical studies or a related technical field.

• Expertise in FDA regulations (21 CFR Part 210, 211, 820) and cGMPs is essential.

• Proven project management, exceptional communication, and interpersonal skills are vital.

• Experience in handling external manufacturing organizations and proficiency in risk management tools

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts. 

#LI-Hybrid

This position may be available in the following location(s): US - Bridgewater, NJ

We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

Any exception will have to be authorized by your HR Business Partner.

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com  or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

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