New

Director, Quality Compliance

Woburn, MA

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

The Director of Quality Compliance is responsible for ensuring the organization maintains an inspection-ready, compliant, and efficient Quality System that supports all GxP-related activities. This role oversees the electronic Quality Management System (eQMS), documentation management, data integrity, and the overall compliance infrastructure. The individual will provide strategic leadership and operational oversight for quality systems, risk management, training, and product complaint processes, ensuring adherence to global regulatory requirements, including 21 CFR Part 11 and EU Annex 11.

Principle Responsibilities:

  • Maintain a robust and inspection-ready Quality Management System (QMS).
  • Oversee the validation, integrity, and ongoing compliance of electronic quality systems.
  • Ensure procedures are appropriately authored, reviewed, approved, and updated.
  • Manage the Documentation Management System and ensure all controlled documents meet regulatory standards.
  • Maintain compliant training records and quality documentation in alignment with regulatory expectations.
  • Lead the development and implementation of a GxP training program for relevant personnel.
  • Support the development and tracking of quality metrics and key performance indicators (KPIs).
  • Provide governance and facilitate Quality Risk Management processes, including timely escalation to senior leadership.
  • Lead continuous improvement initiatives for quality systems and processes.
  • Oversee Change Control processes to ensure systematic and compliant change implementation.
  • Manage the Product Quality Review (PQR) and Product Complaint programs, including investigations and Corrective and Preventive Actions (CAPAs).
  • Oversee the Computer System Validation (CSV) program ensuring compliance with 21 CFR Part 11 and EU Annex 11.
  • Serve as a primary quality compliance liaison with cross-functional departments, including Medical Affairs, Regulatory Affairs, and IT.

Qualifications and Education Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
  • Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment.
  • In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems.
  • Strong expertise in risk management, product complaints, change control, and CSV.
  • Proven ability to communicate complex compliance topics clearly to stakeholders at all levels.
  • Excellent leadership, project management, and problem-solving skills.

 

#LI-Hybrid

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Must be able to sit for long periods of time
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
  • May occasionally climb stairs and/or ride elevators
  • The employee must occasionally lift and/or move up to 25 pounds
  • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
  • Other miscellaneous job duties as required

Benefits We Offer:

  • Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
    • Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
    • Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you. 
  • Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
  • Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
  • Start Your Week on a High Note: Indulge in our “Bagel Tuesday” perk, where you can enjoy a fresh bagel on us every Tuesday morning. **Only for On-site/Hybrid colleagues**
  • Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
  • Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
  • Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
  • Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
  • Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
  • Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

 

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The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).

 

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