InvaGen Pharmaceuticals, Inc. QA Director Central Islip, New York Apply Now
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies.
Job Title : QA Director
Organization Name : InvaGen Pharmaceuticals
Location : 550 South Research Place Central Islip, NY 11722
Employment Type : Full Time - Salaried/Exempt
Salary Range : $165,000 - $190,000
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package including a 401(k) savings plan, health insurance, paid time off, and other benefits.
Work Hours/Shift : 8:30 AM - 5:00 PM
Responsibilities/Accountabilities : The general duties and responsibilities of the QA Director include but are not limited to:
- Develop, establish, and maintain Quality Management System as per 21 CFR Part 11 requirements.
- Accountable for ensuring product quality of all manufactured and released products.
- Ensure compliance of products manufactured at the site.
- Maintain the highest standard of data integrity.
- Ensure compliance with cGMP and safety standards.
- Review and approve Deviation, change control, CAPA, complaints, and laboratory non-conformance.
- Accountable for batch disposition based on testing results.
- Develop talent in the Quality organization.
- Serve as a subject matter expert on technical and compliance issues.
- Maintain audit readiness of the facility.
- Conduct management review meetings regarding QMS effectiveness.
- Ensure compliance with documentation practices.
- Investigate and close QMS action items timely.
- Implement and check effectiveness of global CAPA.
- Ensure qualification and validation of equipment and processes.
- Support submission of internal and external audit responses.
Education Qualifications : Minimum a bachelor's degree in science/pharmacy or equivalent; master's degree preferred.
Experience :
- Experience in Operational Quality of pharmaceutical drug products, including Drug Device combination products.
- 10 to 15 years in Operational quality, with 5-7 years in a leadership role in a regulated environment.
- Knowledge of regulatory compliance for drug product manufacturing.
- Excellent technical writing and communication skills.
- Ability to analyze complex data sets.
- Proficient with Microsoft Office and QMS platforms.
Physical Requirements : Able to wear appropriate personal protective equipment and sit at a desk/computer for 75% of an 8-hour period.
Other Information : No remote work available. Relocation available.
Equal Opportunity Employer : Cipla USA & its U.S. Affiliates are committed to equal opportunity without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.
Pre-employment Process : Conditional offer requires satisfactory completion of pre-employment drug testing.
Disclaimer on Pay Ranges : The salary range mentioned is anticipated and may vary based on experience, skills, and location.
#J-18808-Ljbffr