Senior Specialist, 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 Senior Specialist, External Manufacturing Quality is responsible for maintaining quality systems compliance for externally manufactured products and processes throughout the product lifecycle for NDA, ANDA, OTC, Medical Devices, and combination products. The senior specialist is also responsible for managing the electronic document management system and authoring and reviewing SOPs, Test methods, and Specifications.

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

• Author and review of Quality Management SOPs, test methods, and Specifications in the electronic document management system.
• Organize and archive quality management documents such as Master Batch records, Protocols, Test methods, and Specifications.
• Review and approve ELM artwork processes and artwork verification.
• Manage reference/working standards and develop robust procedures for standards management.
• Management of USP Compendial method updates.
• Responsible for collecting and reporting Quality Metrics data in QRB.
• Assist quality management in all audits (FDA, Supplier Audits, other Regulatory agencies).
• Review of Batch records for assigned product portfolios, which includes initiating and reviewing Investigations, CAPAs, Change Controls, etc.
• Primarily supports Bausch Health EMQA US External Manufacturing Quality Assurance. 
• Senior Quality Specialist will be the SME for the quality systems such as Document Management, Artwork review, USP Compendial methods and management of reference standard.
• 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 routine support related to current commercialized products.
• Support other departmental activities as assigned.

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.

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