Sr. Manager Quality Compliance

Position Summary

The Senior Quality Manager, Quality Compliance is responsible for leading key compliance functions within the Quality Management System (QMS). This role oversees the day-to-day operations of the Post-Market Surveillance and Complaint Handling Program, Internal Audit Program, Supplier Quality Management, Change Control processes, and Annual Compliance Reporting. The ideal candidate will ensure these programs are effectively implemented and maintained in accordance with applicable regulatory requirements, industry standards, and company policies. This role plays a critical part in driving continuous improvement and sustaining a strong culture of quality and compliance across the organization.

Essential Duties and Responsibilities

• Serve as co-administrator of the Quality Management System (QMS), ensuring effective operation and compliance across all functions.
• Lead and manage the Post-Market Surveillance and Complaint Handling team, ensuring timely and accurate investigation and reporting.
• Oversee the Quality Planning program, aligning quality objectives with organizational goals.
• Collaborate with the Pharmacovigilance team to ensure timely and compliant safety reporting.
• Support the development and implementation of the company-wide QMS training program.
• Manage the Internal Audit Program, including planning, execution, and oversight of cross-functional audit activities.
• Lead the Supplier Quality program, including qualification, monitoring, and performance evaluation of suppliers.
• Oversee the Change Control program, including coordination of the Change Control Board and impact assessments.
• Compile, review, and submit Annual Compliance Reports in accordance with regulatory and corporate requirements.
• Support additional quality system processes as needed to maintain QMS effectiveness and regulatory compliance.
• Ensure timely and thorough completion of investigations, CAPAs, and documentation within established timelines.
• Stay current on evolving regulatory requirements (FDA, ISO, EU MDR, etc.) and communicate updates to relevant teams.
• Participate in and support routine internal GMP audits and inspection readiness activities.
• Monitor, analyze, and report quality metrics and KPIs to identify trends and drive continuous improvement.
• Review and contribute to the development and revision of SOPs and quality system documentation.
• Promote and lead continuous improvement initiatives to enhance quality systems and compliance.
• Mentor and develop quality staff, fostering a culture of quality, accountability, and regulatory excellence.
• Uphold and promote Good Manufacturing Practices (GMP) in all activities.
• Perform other related duties and responsibilities as assigned.

Qualifications

• Bachelors or master’s degree in scientific discipline or related technical field.
• Minimum 8 years’ experience in FDA regulated industry.
• Demonstrated organizational and communication skills.
• Must possess strong leadership and analytical skills with team-focused attitude.
• Demonstrated knowledge of FDA regulations (21CFR 820, 211, 210), ISO 13485, Medical Device
• Proven ability to manage priorities and workflow and handle multiple projects and meet deadlines.
• Ability to work independently and as a member of various teams and committees.
• Proven leadership and business acumen skills.
• Ability to deal effectively with diverse group of individuals at all organizational levels.
• Exceptional writing and interpersonal relationship skills.
• Experience with direct contact with FDA and other regulatory bodies.
• Good judgement with the ability to make timely and sound decisions.
• Creative, flexible, and innovative team player.

Supervisory Responsibilities

• Indirectly supervises employees in Quality Assurance
• Carries out supervisory responsibilities in accordance with Vero Biotech’s policies and applicable laws.

•    Standard office and laboratory environment.