Manager, Quality Compliance

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 Manager, Quality Compliance is responsible for leading site-wide Quality and regulatory compliance activities, ensuring adherence to cGMP, GDP, and Data Integrity requirements. This role oversees the Quality Management System (QMS), including internal and external audits, inspection readiness, and continuous improvement initiatives aligned with FDA, ISO 13485, and Health Canada standards.

The position manages audit and compliance processes, supports regulatory inspections, drives CAPA and risk management effectiveness, and ensures timely communication and completion of compliance actions across the organization.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Accountable for strategic leadership, development, and implementation of the Internal and External Audit cGMP QA System for drug/device products.
• Support the development and maintenance of a qualification/certification program for Internal/external auditors.
• Collaborate with Subject Matter Experts (SMEs) to conduct external audits on suppliers, laboratories, and third-party manufacturers as required.
• Ensure associated internal or external corrective action is completed within required timeframes.
• Ensure that CAPAs generated to address Internal Audit findings are audited for effectiveness. Monitor and report the effectiveness of Internal Audits including CAPA plans, effectiveness checks, and risks.
• Ensure associated internal or external corrective action is completed within required timeframes.
• Accountable for the monitoring of the Monitor effectiveness of the QMS by establishing Responsible to coordinate and lead monthly QMS Metrics Meetings and annual Management Review meetings.
• Support and/or host Quality regulatory audits as required.
• Lead and contribute to regulatory /corporate/site inspection readiness preparations.
• Accountable for annual cGMP, GDP, and Data Integrity Training.
• Contribute quality and compliance expertise and guidance to CAPA owners responsible for addressing specific quality issues to ensure robust investigations are conducted for CAPA with established root cause analysis (RCA), action plans and documented effectiveness criteria to assure full and effective closure without repeat CAPA.
• Perform CAPA effectiveness evaluations.
• Manage the Quality Risk Management (QRM) process by ensuring annual product family Risk Management Reports are completed on time.
• Other duties-as necessary such as procedure creating and revision, supporting R&D projects, and participation in projects directly related to quality systems to support business needs, etc.

PERFORMANCE MEASUREMENTS

• On time completion of IQA/External Audits, associated corrective action issuance, and corrective action closure.
• On time monthly QRC and annual Management Review Meetings and follow up and closure of associated actions to identified timelines.
• On-time closure of internal PDI NONCs/CAPAs and/or Findings that are the result of Third-Party Audits to predefined goals.
• On time deliverables assigned as part of R&D projects.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor's degree in a scientific discipline is required, or equivalent related experience. An advanced degree is preferred.

REQUIRED KNOWLEDGE:

• Working knowledge of ICH risk management tools, Lean/Six Sigma concepts, Pharmaceutical/Medical Device QMS, cGMP, GDP, and Data Integrity principles.

EXPERIENCE REQUIRED:

• 5+ years Pharmaceutical and/or medical device quality experience in life sciences technology driven company.
• Direct experience organizing and facilitating to closure Quality related audits.
• 3+ years leadership of people
• Lead Auditor certification is preferred.
• Experience leading and managing US FDA and/or other Drug/medical device regulatory inspections.
• Six Sigma Green Belt preferred.

SKILLS/ABILITIES:

• Strong project management.
• Ability to work as a leader, as a support role, or independently on QA projects and initiatives with minimum supervision.
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
• Ability to work "hands on" in an entrepreneurial, fast paced environment.
• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
• Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
• Strong verbal, written communication skills and computer skills are required.
• Must be goal-oriented, quality-conscientious, and customer-focused.

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.

ANNUAL SALARY

• $120,000 - $140,000 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 such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance.

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, summer hours, flex place/flex time options.