Job Description

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, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

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.

This role serves as the site process owner for the overall Quality Management System and Quality Compliance, with responsibility for the development, implementation, maintenance, and effectiveness of core quality system processes, including Internal and Third Party Audits, Supplier Quality, Management Review, Regulatory Inspection Readiness, Data Integrity, and Quality Metrics.

The Senior Manager Quality & Compliance partners with cross-functional stakeholders to foster a culture of quality, compliance, operational excellence, and continuous improvement while ensuring adherence to FDA, Health Canada, ISO 13485, EU GMP, ICH, and other applicable regulations and standards. The position is accountable for maintaining a state of inspection readiness and driving sustainable compliance strategies that support business growth, product quality, patient safety, and customer satisfaction.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Quality Management System Leadership

• Provide strategic leadership and governance for the site Quality Management System, ensuring compliance with applicable regulatory requirements and industry standards.
• Establish and maintain quality policies, procedures, standards, and governance processes to ensure a compliant and effective quality system.
• Collaborate with Manufacturing, Manufacturing Engineering, Purchasing, Regulatory Affairs, R&D, and Senior Leadership to ensure quality and compliance objectives are integrated into site priorities.
• Support new product introductions, technology transfers, process improvements, digital transformation initiatives, and business growth strategies.
• Lead continuous assessment and enhancement of the QMS to meet evolving business, regulatory, and industry expectations.

Quality Compliance Oversight

• Serve as the site Quality Systems process owner for key QMS elements, including but not limited to: Third Party audits and Internal Audits, Management Review, Quality Audits, Data Integrity, Quality Metrics, Regulatory Inspection Readiness.
• Develop and execute the site quality compliance strategy to ensure ongoing adherence to cGMP, ISO, ICH and applicable FDA regulations and Health Canada requirements.
• Maintain site-wide inspection readiness and lead preparation activities for regulatory inspections, internal audits, and customer audits.
• Ensure annual cGMP, GDP, and Data Integrity Training is conducted.
• Lead, coach, develop, and mentor Quality Management System and Compliance personnel.

Audit Management

• Serve as a key Quality Management System representative during regulatory inspections and compliance-related interactions with regulatory agencies and external auditors.
• Provide strategic oversight of the Internal and Supplier Audit Program, ensuring risk-based audit planning and execution.

CAPA, Investigation & Continuous Improvement

• CAPA, Change Control, Document Management, Training, Quality Risk Management; Ensure robust processes are in place and are inspection ready.
• Provide leadership and oversight and ensure timely and effective CAPAs in responses to audit observations, regulatory findings, nonconformances, and compliance commitments.
• Ensure audit observations are appropriately investigated with robust root cause analysis, risk assessed and remediated through effective CAPA implementation.
• Ensure risk assessments are conducted, maintained, and periodically reviewed for products, processes, systems, suppliers, and quality events.
• Identify, monitor, and mitigate compliance and quality system risks through data-driven decision making and drive continuous improvement initiatives utilizing Quality Risk Management, Lean, Six Sigma, and operational excellence methodologies.
• Lead enhancement and optimization of electronic Quality Management Systems (eQMS).

Quality Metrics & Management Review

• Establish and maintain site Quality Metrics and Key Performance Indicators (KPIs) that measure the health and effectiveness of the Quality Management System.
• Lead monthly Quality Review and annual Management Review meetings.
• Perform other duties as assigned.

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 and closure of associated actions to identified timelines.
• 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 is required, or equivalent related experience.
• An advanced degree is 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.
• Experienced ownership of 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.

SALARY RANGE

• $160,000 - $190,000 ANNUALLY, plus bonus

PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:

• 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)

Many other voluntary benefit plans and perks such as: 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, a health club rebate program and more

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave