Sr. Manager Quality Compliance

About the role

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas—Healthcare, Sani Professional, and Contract Manufacturing—PDI develops, manufactures, and distributes leading-edge products for North America and the world. The Senior Manager, Quality & Compliance is responsible for providing strategic leadership, oversight, and continuous improvement of the site Quality Management System (QMS) to ensure ongoing compliance with applicable regulatory requirements and industry standards for pharmaceutical, medical device, cosmetic, and EPA manufacturing operations.

Responsibilities

• Quality Management System Leadership: Provide strategic leadership and governance for the site QMS; establish and maintain quality policies, procedures, standards, and governance processes; collaborate with cross-functional teams to integrate quality and compliance objectives; support new product introductions, technology transfers, process improvements, digital transformation, and business growth strategies; lead continuous assessment and enhancement of the QMS.
• Quality Compliance Oversight: Serve as the site Quality Systems process owner for key QMS elements, including third-party and internal audits, management review, quality audits, data integrity, quality metrics, and regulatory inspection readiness; develop and execute the site quality compliance strategy; maintain inspection readiness and lead preparation for regulatory, internal, and customer audits; ensure annual cGMP, GDP, and data integrity training is conducted; lead, coach, develop, and mentor QMS and compliance personnel.
• Audit Management: Serve as a key QMS representative during regulatory inspections and compliance interactions; provide strategic oversight of the internal and supplier audit program, ensuring risk-based audit planning and execution.
• CAPA, Investigation & Continuous Improvement: Ensure robust processes are in place for CAPA, change control, document management, training, and quality risk management; provide leadership and oversight for timely and effective CAPAs; ensure audit observations are investigated with robust root cause analysis and remediated through effective CAPA; conduct and maintain risk assessments for products, processes, systems, suppliers, and quality events; identify, monitor, and mitigate compliance and quality system risks; drive continuous improvement initiatives using quality risk management, Lean, Six Sigma, and operational excellence methodologies; lead enhancement and optimization of electronic QMS (eQMS).
• Quality Metrics & Management Review: Establish and maintain site quality metrics and KPIs; lead monthly Quality Review and annual Management Review meetings.

Performance Measurements

• Successful regulatory and third-party audit outcomes.
• On-time closure and effectiveness of FDA and third-party CAPAs.
• On-time monthly QRC and annual Management Review meetings and follow-up of associated actions.
• On-time deliverables assigned as part of R&D projects.
• QMS effectiveness as measured through Management Review outcomes and site quality KPIs.
• Reduction of recurring compliance issues and systemic quality risks.
• Successful delivery of strategic quality improvement initiatives.

Qualifications

Education/Certification

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.

Required Knowledge

• Extensive knowledge of pharmaceutical, medical device, and/or cosmetic Quality Management Systems.
• Expert knowledge of FDA regulations (21 CFR Parts 210, 211, 820), ISO, Health Canada, ICH guidelines, GDP, and data integrity requirements.
• Extensive understanding of quality risk management, regulatory inspection management, audit practices, and compliance frameworks.
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies.

Experience Required

• 10+ years of progressive Quality Assurance, Quality Systems, and Compliance experience within a life sciences technology-driven organization.
• 10+ years of leadership experience managing Quality Systems, Compliance, or Quality Assurance teams.
• Proven experience owning site-wide Quality Management Systems.
• Proven experience leading regulatory inspections and managing interactions with FDA, Health Canada, and other regulatory agencies.
• Significant experience managing audits, CAPA systems, risk management processes, and compliance remediation programs.
• ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CMQ/OE), Six Sigma Green Belt or Black Belt preferred.

Skills/Abilities

• Strategic leadership with the ability to influence all levels of the organization.
• Strong business acumen and ability to balance compliance requirements with operational objectives.
• Exceptional proactive problem-solving, risk assessment, and decision-making capabilities.
• Strong project and change management skills.
• Excellent verbal, written, presentation, and executive communication skills.
• Proven ability to lead cross-functional teams and drive organizational change.
• Highly collaborative with strong stakeholder management capabilities.
• Ability to successfully manage multiple priorities in a dynamic, fast-paced regulated environment.
• Results-oriented with a strong commitment to quality, compliance, patient safety, and continuous improvement.

Working Conditions

• No hazardous or significantly unpleasant conditions.
• Primarily office-based with occasional travel to manufacturing or laboratory facilities for audits and inspections.
• Some physical activity required during site visits, including walking and standing for extended periods.
• Ability to lift and carry equipment or materials as needed.
• Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.

Pay

$160,000 – $190,000 annually, plus bonus.

Benefits

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)
• Voluntary benefit plans and perks, including legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance, tuition assistance, referral bonus program, paid parental leave, health club rebate program

Schedule

• Sick leave
• Generous vacation and holiday time
• Paid parental leave