Senior Associate, Quality Compliance

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Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high‑quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco‑dermatology.

The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to manufacturing and packaging records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance, calibration, qualification, and validation in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA++ principles. The role also provides support during regulatory, corporate, and internal audits.

• Support batch certification activities for commercial distribution in the USA and Canada, ensuring timely execution aligned with production schedules and deliverables.
• Serve as a subject matter expert in sterile manufacturing and packaging processes.
• Review investigations related to site incidents and deviations (planned/unplanned, FARs), ensuring corrective and preventive actions are appropriate and effective.
• Ensure compliance with regulatory requirements for product, process, equipment, and release procedures.
• Provide support during regulatory audits, internal and external inspections, and corporate audits. Responsible for follow‑up on operational findings from FDA and other regulatory bodies.
• Participate in and conduct mock inspections to prepare the facility for audits; assess system gaps and review documentation for compliance with current regulations and cGMP standards.
• Identify compliance issues and support implementation of continuous improvement initiatives.
• Promote adherence to SOPs and policies, ensuring procedures reflect current practices.
• Perform additional assignments as required.

• Corporate office environment
• Manufacturing and production areas
• Laboratory settings
• Warehouse environment
• Field familiarity as needed

• Ability to bend, lift, move, and carry items up to approximately 10 pounds.
• Capable of navigating office, lab, and plant floor environments; standing, walking, and reaching as needed.
• Must be able to wear required personal protective equipment (PPE), including respirators, safety glasses/goggles, and safety shoes.

Up to 30%

• Education: Minimum of a Bachelor's degree required.
• Experience: Minimum of 7 years of experience in the pharmaceutical industry and experience working in a global, multicultural matrix organization.
• Skills &
  
  Competencies:
  
  Strong understanding of cGMPs, ability to work effectively within an international, multicultural matrix organization, proficiency in software applications including MS Word, Excel, PowerPoint, Outlook, Acrobat Reader, Track Wise, LMS, and other relevant systems; knowledge of project management principles and tools; excellent communication, interpersonal, and organizational skills.
• Additional: Participation in seminars and training courses is considered an asset.

The presently‑anticipated base compensation pay range for this position is $90,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan.

Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance…