Senior Supplier Quality Specialist

Date: Nov 27, 2022

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 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.

 

 

Position summary:

  • The External Manufacturing Sr. Supplier Quality Specialist will work directly with Bausch Health's External Manufacturing (EM) suppliers to provide routine support related to commercial product and new product introduction.  This position will work directly with EMs involving Pharmaceutical and Medical devices/Combination products to ensure finished goods External Manufacturing suppliers are compliant to all regulatory and Bausch Health requirements.   In addition, the position is responsible for measuring and reporting key quality metrics to drive quality and efficiency.

 

Key responsibilities:

  • Identify and implement effective quality systems at the Pharma/Medical Device - EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Ensure Finished Good/External Manufacturing suppliers are compliant to all Regulatory and Bausch Health requirements.
  • Support the North America supplier management team in identifying opportunities for improvements.
  • Complete batch releases, non-conformances, quality change requests and CAPAs including root cause investigations related to FG/EM suppliers within required timelines.
  • Proactively investigate, identify and implement best-in-class Quality practices.
  • Provide technical mentorship in resolving quality supply chain issues between Bausch Health and FG/EM suppliers.
  • Escalate critical quality issues from EM suppliers to  Senior Quality Management.
  • Support quality disciplines, decisions, and practices across Bridgewater, NJ site.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers.
  • Track and Trend all quality Inputs (Non-conformances, CAPAs, root cause, change management) and Identify adverse trends and institute corrective/             preventive actions and related effectiveness verifications.
  • Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board, Material Review Board, Local Change Board and Critical Action Committee.
  • Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies, License customer audit) that occur at the Bridgewater site.

 

Qualifications and experience:

  • Master’s degree in Pharmaceutical discipline or equivalent (Biomedics, Pharmacy, materials, etc) or related technical field (microbiology, chemistry, mechanical, etc) is required. Bachelor’s degree and/or relevant work experience will be taken into account in lieu of degree requirements.
  • A minimum of 5 years’ experience within a Pharmaceutical Industry (minimum 2-3 years in the Pharmaceutical Quality Organization) is required.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE)
  • Experience with Root Cause Analysis tools and Technical writing in FDA regulated environment is required.
  • Excellent communication skills (verbal and written).
  • Ability to successfully influence others within project teams regarding quality or compliance concerns.
  • Excellent organizations and presentation skills.
  • Ability to travel to supplier sites as required.
  • Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities.
  • Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
  • Demonstrated expertise in implementing and maintaining quality systems with emphasis in supplier management controls.
  • Familiar with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971.
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes).
  • Experience in electronic quality system modules such as Compliance Wire, Trackwise, Documentum, etc.
  • Expertise in providing creative solutions to complex issues.

 

 

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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.