Manager, Quality Assurance Jobs

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 primary responsibilities of the QMS Manager are to monitor and manage the Quality Systems and to evaluate change management to the process and/or product risks of External Manufacturing Organizations. The QMS Manager is the business process owner for the quality systems such as change controls, CAPAs, Product Quality Complaints, and Quality Metrics program. This highly visible role serves as a subject matter expert and cross-functional influence that impacts departmental performance.

Responsibilities

• Manages the Complaint Review Board to review complaint trending with a cross-functional team.
• Responsible for implementing and maintaining the QMS processes and support to achieve constant audit readiness.
• Responsible for developing and implementing a global change control process.
• Responsible for managing the Change Control Quality System for all GMP activities and working with responsible cross-functional teams to ensure timely evaluation and approval.
• Reviews, evaluates, conducts risk and impact assessments, and approves and closes the change controls.
• Leads Field alert report process and recalls for the US market.
• Performs other tasks as assigned.
• Oversee complaint management process in compliance with directives/ country regulations, process improvements, metric tracking, and risk mitigation activities.
• Review and approve Corrective and Preventive Actions (CAPA), CAPA Effectiveness for Quality Events, Change Controls, and Customer Complaints.
• Communicates effectively with cross-functional stakeholders on the change control process matters.
• Supports QMS implementation and Quality Systems harmonization efforts as needed.
• Compiles applicable quality metrics data, identifies trends and escalates during the monthly Quality Review meetings.
• SME support during internal, external, and health authority inspections at EMQA US function.
• Run the Change Control Review weekly/biweekly meetings with the cross-functional team, generate meeting minutes, follow up on action items, and facilitate resolution when required.

Qualifications

• Management experience is required
• Proficient in risk management tools is preferred.
• Proven track record of successfully working with a cross-functional team in a fast-paced and dynamic environment.
• Demonstrated project management, leadership, and strong communication and interpersonal skills.
• Expert knowledge of FDA regulations (21 CFR Part 210, 211, 820) and cGMPs is required. Working knowledge of ISO 13485 and QSR requirements and quality system development and management. Medical Devices and/or pharmaceutical manufacturing experience is required
• 10 years of quality experience in pharma or medical devices, with 7 years of Quality experience and significant Change Control, Product Complaints and CAPA management in a cGMP/FDA-regulated environment, including successful interactions with regulatory agencies.
• Ability to travel to supplier sites as required.
• Bachelor of Science in Pharmaceutical discipline or technical field.
• Proven communication, leadership, and project management skills, particularly with global initiatives.
• Experience with managing Regulatory inspections is highly preferred.

\#LI-Hybrid

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

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 [email protected] 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-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

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