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Role Description Summary The Compliance Manager is responsible for providing quality direction and resource support for quality compliance matters that impact the site including internal audits, supplier/vendor qualification, inspection readiness, supporting client audits and regulatory inspections, risk assessments, cGMP issues and QMS gap remediation. Additionally the compliance manager will be responsible for reviewing and approving change controls that impact site compliance including process equipment and utility system changes. The role also has the responsibility to define, implement and drive continuous improvement projects and system enhancements.
Description of KEY responsibilities:
• Conducts internal cGMP audits for manufacturing and distribution operations, including manufacturing, packaging, label control storage, warehousing, distribution, laboratories maintenance, calibration and pharmaceutical technology to ensure compliance with cGMP's, SOP's and DEA regulations.
• Carries out auditing responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Ensures compliance with supplier qualification program for the site and conducts external current Good Manufacturing Practice (cGMP) audits for outside service suppliers and contractors.
• Participates in the resolution of issues found during audits in conjunction with quality assurance, manufacturing, regulatory affairs and research and development functions.
• Assists in FDA inspections and third party audits.
• Researches new and developing trends in cGMPs and serves as a compliance information resource. • Ensures project deadlines and performance standards are established and met.
• Follows-up on internal and external action items as well as FDA commitments to ensure timely completion.
• As it relates to site equipment qualification deliverables, responsible for the review/approval of qualification documentation deliverables including qualification/validation plans, functional/end user requirements, risk assessments, test plans, test summary reports, test scripts, data migration plans/reports, traceability matrices, validation summary reports and final release and approval.
• Identifies, implements and/or drives continuous improvements projects at the site in accordance with site continuous improvement plan including deviation reduction and human error reduction.
• Supports Site Compliance Lead with the management of audit systems, QMS changes, site continuous improvement projects, capital improvements projects and corporate sponsored computer systems rollouts.
Experience and education required Essential:
• Bachelors of Science Degree in relevant field or equivalent experience is required.
• A minimum of 8 years of progressive experience in an FDA regulated industry in pharmaceutical Quality Control, Quality Assurance, Manufacturing or Packaging.
• A minimum of 2 years of experience leading or participating in pharmaceutical auditing.
• An equivalent combination of education and experience may be substituted.
• Experience in authoring or approving qualification protocols, non-conformities, change requests, SOPs, validation plans and reports is required. Desirable:
• ASQ Certified Quality Auditor.
• Experience in Lean Six Sigma problem solving methodology.
Skills and specific knowledge required Essential:
• Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands.
• Knowledge of Regulatory Procedure FDA 21 CFR Part 11 with good understanding of GxP related processes.
• Ability to adapt to a fast and dynamic environment.
• Ability to follow procedures and produce/maintain supporting documentation.
• Excellent written, oral, and interpersonal communication skills.
• Excellent time management skills.
• Highly self-motivated, self-directed, and attentive to detail.
• Ability to communicate effectively with senior management.
• Principles and practices of internal and external auditing in the pharmaceutical field including the use of audit tools and systems-based audits. Desirable:
• Prior exposure to manufacturing, packaging, supply chain and/or logistics operations would be beneficial.
Education Please refer to "Qualifications" EOE Statement
EOE Statement EOE Minorities/Females/Protected Veterans/Disabled
Equal Opportunity is the Law poster: English