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, Site Compliance is responsible for the site Quality regulatory compliance activities and also for the implementation, management, and monitoring of the performance of the Quality Management System (QMS). This position will ensure CGMP, GDP, and Data Integrity training is conducted at appropriate intervals. This position has the responsibility and authority for the implementation and effectiveness of the QMS internal and external audit program in alignment with Pharmaceutical Good Manufacturing Practices 21 CFR 210/211, FDA Medical Device Good Manufacturing Practices 21 CFR 820/ISO 13485, Health Canada, and ICH. This role will serve as a resource to the site Quality team by facilitating and leading Third Party /QMS Regulatory audits and will ensure and directly support site inspection readiness activities. This position will provide regular inspection updates to PDI leadership as is accountable to ensure that internal/external and Third Party/QMS Regulatory audit responses are completed within the agreed timeframes. This position will ensure annual risk management reports are completed for drug/device products and is responsible to ensure QMS data is reviewed with Management at defined intervals. This position will also serve as a resource to the CAPA/NONC team to help identify root cause as well as drive change and continuous improvement.

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, maintaining oversight of the Rik Register, and acting as chairperson during Risk Management Board meetings.
• Other duties- as necessary such as procedure creating and revision, 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.
• Monthly QRC and annual Management Review Meetings and follow up and closure of associated actions.
• Support on-time closure of internal PDI NONCs/CAPAs and/or Findings that are the result of Third-Party Audits to predefined goals.
• Qualification of internal/external auditors.
• On time completion of monthly and annual Risk Management activities

QUALIFICATIONS:

EDUCATION/CERTIFICATIONS

• 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 a 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

SALARY RANGE

• $135,000 - $150,000 annually

BENEFITS

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

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

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