Senior Manager, Quality Systems

Purpose

Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards. Act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, enabling product quality, patient safety, and regulatory readiness.

Key Responsibilities

• Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
• Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
• Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
• Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
• Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
• Ensure effective document and record control, release processes, and electronic QMS (eQMS) utilization and optimization.
• Provide quality support for manufacturing transfers, scale-up, technology transfers, and process validation/changes.
• Coach and mentor site quality teams and cross-functional partners on quality system expectations, investigations best practices, and compliance culture.
• Prepare and present quality metrics and dashboards to site leadership; drive data-driven continuous improvement.
• Interface with regulatory agencies during inspections and regulatory submissions as required.
• Manage, hire, and develop direct reports (if applicable); foster a culture of accountability and continuous learning.

Qualifications

Required:

• Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• A minimum of 8 years of progressive experience in quality systems within pharmaceutical, biotech, medical device, or regulated industries.
• In-depth knowledge of cGMP, 21 CFR Part 210/211/820 (as applicable), ISO 13485 (if medical device), ICH Q10, and other relevant regulations and guidance.
• Proven experience with eQMS platforms (EtQ, TrackWise, etc) and quality metrics/reporting tools.
• Experience with change control or PLM systems (Agile, Windchill, etc.).
• Strong experience in CAPA management, root-cause analysis techniques (5 Whys, RCA, fishbone), and investigation governance.
• Demonstrated experience leading audits and interacting with regulatory inspectors.

Preferred:

• Experience with Lean, Six Sigma, or continuous improvement methodologies; certification preferred.
• Prior experience in supplier quality management and audit programs.
• Familiarity with validation strategies for processes, equipment, and computerized systems.
• Experience leading cross-functional change control and product transfer activities.
• Strong leadership and people management skills; ability to influence without authority.
• Excellent written and verbal communication; able to present to senior leadership and cross-functional teams.
• Analytical thinker with strong problem-solving skills and attention to detail.
• Project and stakeholder management skills; able to prioritize and deliver results in a matrix environment.
• Commitment to building a culture of quality and compliance.
• Office and manufacturing floor presence required; PPE and site access per safety protocols.

Other: Travel occasional to domestic sites/suppliers and regulatory inspections (as required). This role requires demonstrated integrity, adherence to compliance standards, and the ability to operate in a regulated environment.