Associate QA Systems and Process QMS Director

The Associate QA Systems and Process QMS Director is the QA lead accountable for providing organizational guidance, support and act as business owner for Quality Management Systems (QMS), to ensure a fit-for-purpose, compliant and timely execution of complex Quality Events (Change Requests, Change Actions, Deviations, CAPAs, Effectiveness Checks, Issue Escalations, etc.). This role owns continuous QMS improvement by leading process enhancements, delivering training, reporting metrics, and serving as the system Business Owner.

The Associate QA Systems and Process QMS Director partners closely with QA and cross-functional teams (Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) to identify, elevate, and effectively mitigate issues and risks.

• Champion and Partner QA support for QMS (Deviations, Change Control, CAPA, CAPA Actions, Effectiveness checks, etc.).
• Owns business process for eQMS.
• Provide guidance on QMS use, process requirements, best practices and record completeness.
• Provide QA oversight of Veeva periodic enhancements.
• As a Change Control Process owner and QMS Business owner, drive cross-functional compliance, provide QMS guidance, ensure complete, thorough and timely completion of quality records.
• Own governing procedures and drive continuous improvement to ensure fit-for-purpose, risk based QMS processes.
• Track and trend QMS, provide metrics for Quality Systems Management Review (QSMR).
• Provide monthly Veeva Quality event status reports to QA and functional areas, proactively driving timely record closure.
• Develop and chamption a risk-based strategy across the GxP landscape to identify, manage, and mitigate risks; address potential blind spots; elevate issues; propose solutions; drive continuous improvement; and ensure alignment with key stakeholders and global regulatory standards.
• Own continuous improvements of the eQMS platform and Computer System Validation (CSV) processes to enhance efficiency, compliance, and overall system effectiveness.
• Resolve quality issues, identify and mitigate risk, propose options and solutions, and elevate as needed.
• Serve as the SME for health authority inspections and audits, while fostering strong relationships with internal and external stakeholders to ensure timely documentation, escalation, and resolution of quality issues.
• Manage conflict by actively engaging teams to address issues, seeking diverse views and facilitate identification of options to achieve an equitable solution.
• Drive results and influence others outside of direct authority.
• Manage objective setting and balance commitments to prioritize and complete activities within established timelines.
• Serve as backup to other QMS QA leads and support CSV and Data Integrity (DI) QA activities as needed.
• Performs other duties as assigned.
• Complies with all policies and standards.

No supervisory responsibilities.

Education BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or Equivalent combination of education and applicable experience.

Experience Experience in pharmaceutical or biotech industries, and Quality Systems is preferred. Experience in development of business strategies, metrics, and continuous improvements is preferred. Proven indirect organizational and management skills, ability to manage complex issues, sound…