Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
Job Description Summary
SUMMARY OF POSITION:Provides overall Quality Assurance (QA) management of the batch record review, manufacturing (current Good Manufacturing Practices) cGMP compliance, and product release functions for the manufacturing of pharmaceutical products. Provides QA and cGMP compliance leadership regarding Quality systems and adherence to site, corporate, and regulatory requirements. Key leadership position within the Quality group.
Job Description
Provides overall Quality Assurance (QA) management of the batch record review, manufacturing (current Good Manufacturing Practices) cGMP compliance, and product release functions for the manufacturing of pharmaceutical products. Provides QA and cGMP compliance leadership regarding Quality systems and adherence to site, corporate, and regulatory requirements. Key leadership position within the Quality group.
ESSENTIAL FUNCTIONS:
- Manage the QA team responsible for batch record review, product release, label issuance, sampling and sample management activities
- Write, review and approve exceptions, change controls, and CAPA in the quality system.
- Review and approve out of specification and customer complaint investigations in quality system.
- Lead strategic Quality continuous improvement efforts and projects
- Provide expertise to support site transition to align with drug product expectations
- Lead auditor for the site internal audit system
- Follow all internal and basic cGMP guidelines for pharmaceutical operations
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal polices to assure compliance
- Ability to identify, evaluate and remediate gaps as they pertain to data integrity
- Provides solutions to technical problems of moderate scope and complexity
- Adhere to all safety rules and maintain 100% completion of all safety required training
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
MINIMUM REQUIREMENTS:
Education:
- BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.
Experience:
- Minimum of 8 years' experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment.
- ASQ CQA certification preferred. Proven personnel and project management history.
- Complete knowledge of FDA Code of Federal Regulations (CFR) and International Conference Harmonization (ICH) guidelines, pharmaceutical regulations including current GXP, GLP, or GMP requirements
Preferred Skills/Qualifications:
- Excellent communication and leadership skills.
- Ability to work in and promote a team environment.
- Working knowledge of Six Sigma and/or Lean manufacturing tools.
- Complete understanding and application of principles, concepts, practices, and standards within discipline.
- Ability to lead and influence people.
- Understanding of basic statistical principles
- Expert knowledge of cGMP guidelines and knowledge of US and International pharmaceutical manufacturing regulations.
- Bias toward change, management of change, and achievement of results
- Exercises considerable latitude in determining technical objectives of assignment
- Demonstrated ability to make risk-based decisions regarding product quality and regulatory compliance
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs. Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward. Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life. Endo has global headquarters in Malvern, Pennsylvania. Community Guidelines: 1. Be respectful. Everyone who visits our page should feel comfortable and respected. 2. If we see a comment that violates anything in the following list, it may be removed. • Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional. • Comments that are excessively repetitive and/or disruptive to the community. • Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter. • Comments that appear to be medical advice. We reserve the right to remove a reply for any reason at any time. 3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088. Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.
