Senior Specialist, External Manufacturing Quality

Date: Jun 21, 2024

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch Health

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 Senior Specialist, External Manufacturing Quality plays a crucial role in upholding compliance with Quality Systems governing externally manufactured products and processes across their entire lifecycle within the Rx, OTC, Cosmetic, and Medical Device regulated environment. Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements. With a keen eye for trends, the role involves identifying areas for improvement and implementing efficient, compliant quality processes. Leading process enhancements across EMQA and CMOs fosters compliance improvements and standardization, driving excellence throughout departments.

 

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

 

  • This position will work directly with External Manufacturing Organizations (EMO) involving Pharmaceutical, Medical devices/Combination products, Consumer products /OTC and Biologics to ensure drug products/ Biologics are manufactured as per cGMP regulations and Bausch Health requirements.

  • Identify trends and implement effective, efficient, and compliant quality processes and lead process improvements across EMQA and CMOs to drive compliance improvements, as well as standardization across departments.

  • This position will lead the execution of quality-related activities, including responsibility for measuring and reporting key quality metrics to drive quality and efficiency.

  • Lead and write Non-conformances related to manufacturing and laboratory, stability failures, investigations, perform the root cause analysis and determine appropriate CAPA(s). · Author and process the Change controls in electronic system and conduct impact assessment and risk assessment.

  • Management of internal and external Annual Product reviews (APRs). Author and review the APRs, identify the trends and escalate critical quality issues to Senior Quality Management.

  • Lead and support activities associated with the Document Management system for the EMQA US Operations.

  • Assist quality management in all audits (FDA, Supplier Audits, other Regulatory agencies).

  • Coordinates and leads EMQA personnel through the Compliance Wire, Remarque (TrackWise) system which includes but not limited to Quality Events, Management of Change, Supplier Quality Management, Audits and CAPA workflows.

  • Author and Review SOPs and other departmental procedures.

 

Qualifications/Experience

  • Bachelor of Science in Pharmaceutical discipline or technical field.

  • 5 years quality experience, 3 years minimum in Pharmaceutical or medical device Quality Organization with handling of Annual Product Reviews (APRs), investigations, Change Controls, CAPA management and electronic quality system modules such as TrackWise, EDMS, SAP, etc. 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.

  • Knowledgeable of statistical techniques and application experience.

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

  • Working knowledge of FDA regulations (21 CFR Part 11, 210, 211, 820) and cGMP is required. Experience with managing external agency audits is recommended.

  • Knowledgeable of FDA/QSR requirements and quality system development and management. Medical Devices and/or pharmaceutical manufacturing experience is required.

  • Training and experience in Supplier Management, validation, auditing, statistics preferred. Certified ASQ CQE and/or Lean Six Sigma Green belt preferred.

  • Training or experience in the application of problem-solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis, Fishbone Diagram, 5 Whys).

  • Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles) is preferred.

 

 

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement.