Senior Quality Assurance Manager

3 days ago

West Islip, New York, United States Invagen Pharmaceuticals Full time
About Invagen Pharmaceuticals

Invagen Pharmaceuticals is a leading global pharmaceutical company dedicated to delivering high-quality, innovative medicines to patients worldwide. With a strong presence in the US market, we are committed to making a positive impact on people's lives.

Job Title: Senior QA Manager

We are seeking an experienced Senior QA Manager to join our team at Invagen Pharmaceuticals. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products, processes, and systems.

Key Responsibilities:
  • Ensure compliance with current Good Manufacturing Practices (cGMP) and company procedures at our OSD plants.
  • Support site and company-wide objectives through the reporting of department Key Performance Indicators (KPIs).
  • Oversee Unit-3 site operation QA activities, including both Manufacturing and Packaging.
  • Follow standard operating procedures and execute change controls to support business and quality objectives.
  • Establish and maintain cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Regulatory Services, Research & Development, and Supply Chain.
  • Support audit readiness and assisting with audit preparation, regulatory inspections, and customer audits.
  • Support a quality and compliance-focused culture that embraces Root Cause Analysis (RCA) and Continuous Improvement (CI) expectations.
  • Maintain working knowledge of government and industry quality assurance regulations and standards.
  • Establish and maintain effective cross-functional relationships.
  • Supports regulatory inspections and customer audits for the site.
  • Manage the corporate and site programs (i.e., self-improvement audits) to assess and improve the state of compliance of cGMPs.
  • Manage Site Master File and Quality Manual program.
  • Support Change Control & Corrective/Preventive Action commitments resulting from internal audit, customer audit, and agency inspection observations to verify implementation and effectiveness.
  • Communicates shopfloor metrics (deviations, change controls, CAPA, etc.) trends to leadership.
  • Provide leadership to the Quality and Compliance function, manages, and provides development support to department personnel.
  • Provide leadership and coaching to shop floor quality team members.
Requirements:
  • A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required.
  • A master's degree in a field relevant to the position is preferred.
  • Experience working in pharmaceutical QA is preferred.
  • Proficiently speak English as a first or second language.
  • Proficiently communicate and understand (read and write) scientific/regulatory-based 'work' in English.
  • Have excellent organization, learning, and teaching skills required to work in teams.
  • Strong desire towards continuous improvement.
  • Know how to use Microsoft Office programs and other scientific-based software.
Experience:
  • Minimum ten (10) years of experience in quality operations in a pharmaceutical (cGMP/FDA regulated) industry.
  • Minimum five (5) years of management experience.
  • Prior experience in Oral Solid Dosage Manufacturing.
  • Knowledge of regulatory requirements as they pertain to pharmaceutical manufacturing and related GMP as per company policies and SOPs.
Physical Requirements:
  • Work standing or walking unassisted for 75% or greater of an 8-hour period.
  • Unassisted lifting up-to 10 kg, may be required.
  • Able to wear appropriate personal protective equipment at all times, when required.
  • Sitting at a desk and/or working at a computer or other 'screen' 75% or greater of an 8-hour period.
Other Information:

This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.

Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required.

The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.

No remote work available. Relocation available.

Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.

If you require a reasonable accommodation to make your application or interview experience a great one, please contact us.

Applicants who receive a conditional offer must satisfactorily complete pre-employment drug testing.

Disclaimer on Pay Ranges:

The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location.

In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

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