Senior Quality Assurance Manager

4 weeks ago

Central Islip, New York, United States Invagen Pharmaceuticals Full time

About the Role:

Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. As a Senior Quality Assurance Manager at Invagen Pharmaceuticals, you will play a crucial role in ensuring the quality and compliance of our products.

Key Responsibilities:

  • Support site and company-wide objectives through the reporting of department Key Performance Indicators
  • 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 to meet site and corporate objectives
  • Support audit readiness and assisting with audit preparation, regulatory inspections, and customer audits
  • Support a quality and compliance focused culture which embraces RFT and CI expectations in partnership with the site leaders
  • Maintain working knowledge of government and industry quality assurance regulations and standards
  • 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
  • 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 to study 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
  • Know how to use Microsoft Office programs and other scientific based software
  • Minimum ten (10) years of experience in quality operations in a pharmaceutical (cGMP/FDA regulated) industry
  • Minimum five (5) years of management experience
  • Knowledge of regulatory requirements as they pertain to pharmaceutical manufacturing and related GMP as per company policies and SOPs
  • Able to wear appropriate personal protective equipment at all times, when required

About Invagen Pharmaceuticals:

Invagen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants.

What We Offer:

  • A fulfilling career and competitive salary
  • A comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

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