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2 months ago
The Director, Quality Systems and Compliance is a senior leader accountable for the quality oversight and compliance support of the GxP quality systems and ensuring continuous process improvement within the Quality Assurance department. This position will also be responsible for the management and support of the inspection readiness program.
Key Responsibilities- Develop, improve, and implement risk-based and appropriate quality management systems, policies, and procedures in support of GxP work.
- Lead the quality systems changes, new initiatives, and process improvement to support evolving regulations and international standards.
- Ensure regulation compliance of quality systems across GxP activities including review and approval of quality documents and continuous improvement.
- Collaborate with cross-functional teams to ensure alignment on quality objectives and priorities.
- Establish and manage the performance and effectiveness of quality systems and processes; SOPs, deviations, CAPA, change control, investigations, audits, and training.
- Develop quality metrics, including trending and reporting data for Management Reviews.
- Collaborate with internal and external teams in addressing quality compliance events and proactively identify and mitigate issues.
- Support the implementation of electronic QMS.
- Identify compliance risks and implement risk mitigation plans to enable innovative solutions.
- Develop inspection readiness program, mock inspections, and support and participate in regulatory authority inspections.
- Establish or support Quality Agreements with applicable contractors.
- Support GxP vendor qualification activities and audit program.
- Perform other duties as required.
- Minimum a bachelor's degree in a relevant scientific discipline or equivalent.
- Minimum of 10 years of pharmaceutical industry experience in QA with extensive knowledge of Quality Management Systems.
- Exhibit leadership conduct with high standards, professionalism, and ethics.
- Implementing phase appropriate and commercial quality systems.
- In-depth knowledge of GxP regulations and Guidance (FDA, EU, ICH).
- Experience in regulatory inspections and inspection readiness.
- Experience working with Contract Service Organizations.
- Proven ability to thrive and enable success in a cross-functional and collaborative environment.
- Ability to multi-task, shift priorities, work in a fast-paced environment, and problem-solving.
- Detail oriented, well organized, and strong project management skills.
- Team leadership experience within a cross-functional matrix environment.
- Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
- Ability to travel as needed for 10%.
- The base salary range for this role is $196,900 – $217,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
- Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
- A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
