Principal Engineer, External Manufacturing Quality

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.

The Principal oversees External Manufacturing Quality, consisting of approval of change controls, investigations, product impact assessments and leading FAR assessments and escalation meetings. Responsible for reviewing and approving APRs, product disposition, CAPA, quality metrics, test method and specification. In addition, this job role provides leadership support to the team members responsible for the tactical execution of tasks associated with product portfolio. This highly visible role serves as a subject matter expert and cross-functional influence that impacts departmental performance.

Key Activities and Responsibilities –

• Responsible for managing the assigned external manufacturing product portfolio for all GMP activities consisting of a review of batch records and batch disposition by collaborating with cross-functional teams.

• Responsible for review and approval of laboratory, stability, product and process investigations and determine the effective CAPAs from the root cause and conclusions.

• Responsible for FAR assessments, conducting escalation, technical review, and critical action committee meetings.

• Review and approve APRs.

• Reviews, evaluates, and conducts risk, and impact assessment; approves the change controls and supplier risk assessments.

• Conduct daily huddle meetings with cross-functional teams to prioritize the batch release priorities and dispositions.

• Responsible for implementing and maintaining the QMS processes and support to achieve constant audit readiness.

• Collect the data for Supplier scorecards and quality review meeting, identifies trends, and escalates during the monthly Quality Review meetings.

• SME support during internal, external, and health authority inspections at EMQA US function.

• Communicates effectively with cross-functional stakeholders on the change control process matters.

• Supports QMS implementation and Quality Systems harmonization efforts as needed.

• Performs other tasks as assigned.

Scope of Position –

• Primarily supports Bausch Health EMQA US External Manufacturing Quality.

• The Principal Quality Specialist is the business process owner for the quality systems such as change controls, CAPAs, Non-conformance and Quality Metrics program.

• This position will work directly with Bausch Health External Manufacturing (EM) suppliers and internal business stakeholders, involving Pharmaceutical, Consumer products and Medical Devices, to provide sustaining quality and compliance leadership, and routine support related to current commercialized products.

• May be requested to support other Bausch Health departments as needed.

Qualifications –

• Bachelor of Science in Pharmaceutical discipline or technical field.

• Expert knowledge of FDA regulations (21 CFR Part 210, 211, 820) and cGMPs is required.

• Previous experience in handling of external manufacturing organizations is preferred.

• Demonstrated project management, leadership, and strong communication and interpersonal skills.

• Proficient in risk management tools is preferred.

• Proven communication, leadership, and project management skills.

• Ability to travel to supplier sites as required.

• Proven track record of successfully working with a cross-functional team in a fast-paced and dynamic environment.

Experience –

• 8 years of quality experience in pharma or combination products consisting of handling in investigations, Change Controls, and CAPA management in a cGMP/FDA-regulated environment, including successful interactions with regulatory agencies.

• Hands-on experience in manufacturing, packaging, and Laboratory operations involving reviewing batch records, root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram and 5 Whys etc.)

• Experience in electronic quality system modules such as Trackwise, EDMS, SAP, etc.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating 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.

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This position may be available in the following location(s): [[location_obj]]

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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To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/6d14a0b2d6ae791286e49cc8358d2a3ef29730f9) .

Bausch Health is an EEO/AA employer M/F/D/V.