Job Summary:The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation, and continuous improvement of the organization's Quality Management System (QMS) and Regulatory Affairs programs. This role ensures product quality, regulatory compliance, and customer satisfaction while driving operational efficiency across the enterprise. The Senior Manager leads cross-functional quality and regulatory initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports business objectives and global compliance requirements.
Duties & Responsibilities:Quality Management Systems & Strategy:- Oversee the design, implementation, and maintenance of the Quality Management System to ensure compliance with applicable standards and regulations.
- Establish quality objectives, metrics, and performance indicators aligned with business goals.
- Lead the integration of quality principles across product lifecycle activities, including design, manufacturing, and post-market support.
Regulatory Affairs Oversight:- Direct regulatory affairs strategies to support product development, market access, and lifecycle management.
- Ensure compliance with applicable global regulatory requirements and standards.
- Oversee regulatory submissions, change notifications, and communications with regulatory bodies, as applicable.
Leadership & People Management:- Lead, mentor, and develop managers and individual contributors within Quality Assurance and Regulatory Affairs.
- Set performance expectations, conduct performance and compensation reviews, and support succession planning.
- Foster a culture of accountability, continuous improvement, and compliance excellence.
Compliance, Audits & Risk Management:- Ensure audit readiness and lead internal and external audits, inspections, and regulatory assessments.
- Drive timely and effective responses to audit observations, nonconformances, and regulatory findings.
- Identify quality and compliance risks and implement mitigation strategies.
Corrective & Preventive Action (CAPA):- Lead root cause investigations and oversee corrective and preventive action programs.
- Ensure systemic issues are addressed to prevent recurrence and improve product and process quality.
- Monitor effectiveness of CAPAs and continuous improvement initiatives.
Cross-Functional Collaboration:- Partner with Engineering, Operations, Supply Chain, R&D, and Commercial teams to embed quality and regulatory requirements into business processes.
- Provide strategic guidance on quality and regulatory considerations for new and existing products.
Continuous Improvement & Operational Excellence:- Lead quality and efficiency improvement initiatives using data-driven methodologies.
- Promote standardization, simplification, and scalability of quality and regulatory processes.
- Champion continuous improvement culture aligned with organizational values.
Reporting & Communication:- Prepare and present quality and regulatory performance updates to senior leadership.
- Use metrics and trend analysis to inform decision-making and strategic planning.
Experience & Education:- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline.
- 8-10 years of progressive experience in Quality Assurance and/or Regulatory Affairs including 4-5 years of people management experience leading managers and/or cross-functional teams.
Knowledge & Skills Required:- Strong knowledge of Quality Management Systems and regulatory compliance frameworks.
- Demonstrated ability to lead audit programs, CAPA systems, and compliance initiatives.
- Proven leadership skills with experience developing and mentoring high-performing teams.
- Excellent analytical, problem-solving, and decision-making capabilities.
- Effective communication and influencing skills across all organizational levels.
- Ability to balance strategic leadership with operational execution.
Physical Demands (US Only):- Sitting: Often for extended periods at desks or meetings.
- Standing or walking: Occasionally for meetings or office tasks.
- Using computers: Typing and using office equipment.
- Lifting: Light, less than 10 pounds.
- Repetitive motions: Frequent use of keyboard and mouse.
Environmental Conditions:- Workspace: Climate control (air conditioning or heating) to ensure comfort.
- Lighting: Adjustable lighting to reduce eye strain.
- Noise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary.
- Ergonomics: Workstations with desk and adjustable chairs to support good postures.
- Ventilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building.
