Compliance Manager manages the compliance programs, policies, reporting, and practices for an organization or business. Ensures that all activities follow regulatory requirements related to the governance of the organization as well as any industry-specific or location-specific laws. Being a Compliance Manager oversees internal controls and auditing systems that monitor and report on regulated activities and processes. Implements risk-based compliance testing of existing procedures and controls to identify, detect, and correct noncompliance. Additionally, Compliance Manager evaluates and implements changes to compliance processes due to new or amended regulations. Delivers communication and training initiatives that inform stakeholders about compliance requirements. Requires a bachelor's degree or equivalent. Typically reports to a director. The Compliance Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Compliance Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
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.
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.
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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.
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