Compliance Manager

Description:

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.

• 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.
• Responsible to coordinate, review and lead monthly QMS Metrics Meetings and annual Management
• 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.

Skills: Quality assurance, Compliance, Quality management system, fda, cgmp, Audit, Medical device, pharmaceutical

Additional Skills & Qualifications:

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

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

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.

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.

Experience Level:

Expert Level

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.