Senior Manager, Quality Assurance and Compliance

4 days ago

Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

The Senior Manager, Quality Assurance and Compliance will be responsible for ensuring the quality and compliance of medical devices and combination products manufactured by Sun Pharmaceutical Industries, Inc. This includes ensuring that all medical devices meet established specifications and that the company's Quality Management System (QMS) is compliant with regulatory requirements.

Key Responsibilities
  • Lead and manage the Quality Assurance and Compliance team to ensure effective implementation of QMS and regulatory compliance.
  • Develop and implement quality and compliance policies, procedures, and training programs to ensure employee understanding and adherence.
  • Conduct regular audits and assessments to ensure compliance with regulatory requirements and company policies.
  • Collaborate with cross-functional teams to ensure quality and compliance in all aspects of product development, manufacturing, and distribution.
  • Develop and maintain relationships with regulatory agencies, including the FDA and Health Canada, to ensure compliance with regulatory requirements.
  • Manage and maintain device history records, complaint files, and other quality and compliance documentation.
  • Develop and implement corrective and preventive actions to address quality and compliance issues.
  • Provide training and guidance to employees on quality and compliance procedures and policies.
  • Stay up-to-date with regulatory requirements and industry developments to ensure the company remains compliant and competitive.
Requirements
  • Bachelor's degree in a scientific field, such as biology, chemistry, or engineering.
  • Minimum 8-10 years of experience in quality assurance and compliance in a medical device manufacturing environment.
  • Strong knowledge of medical device regulations, including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), and CMDR (SOR/98-282).
  • Experience leading and/or supporting medical device regulatory inspections, corporate audits, and third-party audits.
  • Strong knowledge of device history records, complaint files, and other quality and compliance documentation.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and regulatory agencies.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve quality and compliance issues.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
Preferred Qualifications
  • Experience with the manufacture and testing of radiopharmaceuticals.
  • Knowledge of Trackwise and other electronic quality management systems.
  • Experience with SAP, EDMS, LMS, and other quality management systems.
  • Strong working knowledge of MS Office software.
Compensation and Benefits

The base compensation pay range for this position is $140,000 - $150,000, with a bonus target. The company offers a comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

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