US Quality Lead, Quality Compliance & Change Control

Date: Mar 22, 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.

 

 

Join our team as a US Quality Lead for Quality Compliance & Change Controls! In this pivotal role as an individual contributor, you will spearhead pharmaceutical quality assurance efforts and drive seamless change control management. As the go-to expert, you will manage the Change Controls within the Quality System, ensuring timely evaluation, review, and approval, and closure activities. Reporting directly to the Manager, Quality, you will champion quality systems like Change Controls, CAPA, Product Complaints, and regulatory audits. Your influence will extend across departments, shaping cross-functional performance and leaving a lasting mark on our operations. If you're ready to make a significant impact and embark on a transformative career journey, apply now and be part of our dynamic team! 

 

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

 

RESPONSIBILITIES:

  • Responsible for managing the Change Control Quality System for all GMP activities and working with cross-functional teams to ensure timely evaluation, review, and approval.
  • 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.
  • Reviews, evaluates, conducts risk and impact assessments, approves and closes the change controls.
  • Partner with External manufacturing organizations to ensure they manage product quality complaints effectively, efficiently, and in compliant way.
  • Manage the triage, effective, timely investigation of Product Quality Complaints (PQC). Review and approve PQC for Pharmaceutical and Combination products, ensuring compliance with internal policies/procedures and regulatory requirements.
  • Analyze PQC data, monitoring the risk profile of contract manufacturers and products proactively to manage emerging product and performance issues.
  • Support Field alert reporting process and recalls for the US market.
  • Review and approve Corrective and Preventive Actions (CAPA).
  • Responsible for implementing and maintaining the QMS processes to achieve sustainable quality.
  • Compiles 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.
  • Supports QMS implementation and Quality Systems harmonization efforts as needed.

 

QUALIFICATIONS:

  • 7+ years of quality experience in pharmaceuticals and combination products, including handling Change Controls, Product Quality Complaints, and CAPA management in FDA-regulated environment, including successful interactions with regulatory agencies.

  • Bachelor of Science in Pharmaceutical discipline or technical field.

  • Experience in electronic quality system modules such as Trackwise, EDMS, SAP, etc

  • Expert knowledge of FDA regulations (21 CFR Part 210, 211, 820) and cGMPs is required.

  • Previous experience in handling of external manufacturing organizations is preferred.

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

  • Proficient in risk management tools is preferred. · Proven communication, leadership, and project management skills.

  • Ability to travel to supplier sites as required.

  • Proven track record of successfully working with a cross-functional team in a fast-paced and dynamic environment.

 

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.