Principal Quality Specialist, External Manufacturing

Date: Nov 22, 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. 

 

As the Principal Quality Specialist, you will lead the execution of quality-related activities, including but not limited to:

  • Quality control laboratory investigations, stability failures, review and approval of stability protocols, test methods and specifications new quality system/methodologies implementation, training, deviations, CAPA, change management, problem-solving, product and process improvement/acceptance activities.
  • This position will also work directly with Bausch Health Finished Good (FG)/External Manufacturing (EM) suppliers, involving Pharmaceutical and Consumer products, to provide sustaining quality and compliance leadership, and routine support related to current commercialized products.
  • In addition, the position is responsible with activities engaging Product Annual Reports and measure, and report key quality metrics to drive quality and efficiency.

 

Additional responsibilities:

  • Identify and lead the implementation of effective quality systems at the Medical Device/Pharma/EM supplier sites to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
  • Complete Non-conformances and CAPAs related to FG/EM suppliers within required timelines.
  • Conduct, review, and approval of laboratory investigations such as out-of-specification, and out-of-trend records.
  • Review and approve of Stability Protocols, and reports, identify trends by using statistical analysis.
  • Identify meaningful CAPAs and drive continuous improvement projects.
  • Review, approve, and implementation of change controls.
  • Perform, review and approve Elemental impurities, Nitrosamine, Benzene and extractable and leachable risk assessments.
  • Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Bausch Health requirements. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers.
  • Provide leadership and support the North America supplier management team in identifying opportunities for improvements.
  • Proactively investigate, identify and implement best-in-class Supplier Quality practices.
  • Provide technical mentorship in resolving quality supply chain issues.
  • Lead quality disciplines, decisions, and practices across Bridgewater, NJ site.
  • Assist EM QA functions, supply chain and R&D organizations in sourcing new FG/EM suppliers.
  • Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies) that occur at the BW site.
  • Directly support management team for activities related to Annual Product Reviews, Management Review, Material Review Board and Critical Action Committee.
  • Scope of Position:
  • The scope of this position is directly related to the Bridgewater NJ External Manufacturing.
  • The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).

 

 

We want to hear from you if you have:

  • Bachelor of Science degree in a pharmaceutical discipline (Bio medics, Industrial Pharmacy, etc.) or related technical field (microbiology, chemistry, etc.) is required.
  • A Master’s degree in Pharmaceuticals or technical-related discipline may be substituted for two years of experience.
  • A minimum of 8 years within a supplier quality organization (minimum 4 years in the pharmaceutical industry is required).
  • Quality Control Laboratory experience is preferable to handle Laboratory investigations and stability failures.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE).
  • Excellent communication skills (verbal and written).
  • Ability to successfully influence others within project teams regarding quality or compliance concerns.
  • Excellent organization and presentation skills.
  • 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.
  • Hands-on experience in manufacturing, packaging, and Laboratory operations.
  • Hands-on experience in reviewing batch records, laboratory data, stability protocols and reports.
  • Strong technical writing skills
  • Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
  • Ability to travel and audit supplier sites and laboratories as required.
  • Proven track record of successfully working with cross-functional teams in a fast-paced and dynamic environment.
  • Familiar with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971.
  • Extensive experience in root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and the ability to mentor stakeholders in the analysis of process data and metrics to identify the root cause of complex problems and development and implementation of preventative or corrective actions.
  • Experience in electronic quality system modules such as ComplianceWire, Trackwise, SAP, eDMS, etc.
  • Expertise in providing creative solutions to complex issues.

 

#LI-Hybrid

 

 

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.