Senior Quality Manager

About the role

This is an onsite role at our site in Norfolk, Virginia.

Responsibilities

• Develop and implement site-wide quality strategy aligned with corporate objectives and regulatory requirements (QMSR, GMP, ISO, and other global standards) including objectives, and planning to support the strategy.
• Establish and refine key quality metrics, ensuring data-driven decision-making to enhance product integrity and regulatory compliance.
• Partner with R&D, supply chain, manufacturing, and distribution teams to enhance quality processes across the product lifecycle and drive cross-functional teamwork to improve operational efficiencies, ensuring seamless integration of quality in all aspects of pharmaceutical production.
• Serve as the primary quality representative during regulatory inspections and audits, ensuring adherence to industry and corporate standards.
• Build, mentor, and lead a high-performing quality assurance and quality control (QA/QC) team, fostering a culture of collaboration and accountability.
• Empower team to lead investigations into deviations, CAPA (Corrective and Preventive Actions), and change control processes to improve operational resilience and ensure timely product release and market supply by resolving quality-related issues effectively.

Requirements

• Must have a thorough knowledge of QMSR, GMP, ISO and other relevant regulatory requirements as applied to medical device development, manufacturing and distribution.
• Demonstrated independent decision-making ability applying regulations and standards related to the manufacturing and distribution of medical device products.
• Demonstrated management ability including organizational design and employee selection, development, motivation and performance.
• Demonstrated ability to achieve productivity goals collaboratively without sacrificing quality in a manufacturing environment.
• Demonstrated understanding of interactions and interdependency of elements within the quality system in a pharmaceutical manufacturing organization.
• Must be able to work with all levels of employees, including hourly production employees through senior management.
• Possess excellent written and oral communication skills and the demonstrated ability to communicate with individuals of varying backgrounds.

Qualifications

• A Bachelor’s Degree in a technical field is required.
• 7-10 years of work experience in medical device quality, preferably in manufacturing environments.
• 5 years’ experience with direct management responsibility.
• CQE/CQM preferred.

Skills

• Thorough knowledge of QMSR, GMP, ISO and other relevant regulatory requirements as applied to medical device development, manufacturing and distribution.
• Independent decision-making ability applying regulations and standards related to the manufacturing and distribution of medical device products.
• Management ability including organizational design and employee selection, development, motivation and performance.
• Ability to achieve productivity goals collaboratively without sacrificing quality in a manufacturing environment.
• Understanding of interactions and interdependency of elements within the quality system in a pharmaceutical manufacturing organization.
• Excellent written and oral communication skills.

Benefits

• Comprehensive bonus.

Pay

Expected Compensation: $130,000- $160,000 base salary.

Schedule

N/A