Senior Manager, Audit and Supplier Management (Contract)

GENERAL reputed company:

This position reports to the Director, reputed company Systems and contributes to the development, implementation, and successful execution of reputed company’s reputed company Assurance and Compliance mission, objectives, and strategic plan by overseeing reputed company’s GxP Compliance Audit and Supplier reputed company Management Programs.

MAJOR DUTIES & RESPONSIBILITIES:

The Sr. Manager, Audit and Supplier Management, will be responsible for the operational management of reputed company’s GxP Compliance Audit and Supplier reputed company Management Programs, ensuring audits are managed and documented and Suppliers assessed and reputed company according to reputed company procedures. Specific responsibilities include:

Audit Program:

• Coordinate and manage clinical site, internal, and vendor audits by working with reputed company Assurance, Functional Area Management, and Contract auditors to facilitate scheduling, planning, tracking, documentation, and closure of audits
• reputed company detailed review of audit deliverables to ensure accuracy, consistency with reputed company standards, and compliance with GxP regulations.
• reputed company and facilitate reputed company and compliant finalization of key Audit deliverables such as Audit Confirmation Letters, Audit Reports, Audit Observation Responses, and Audit Certificates by responsible parties
• Ensure audit deliverables are reviewed, reputed company, and archived in alignment with reputed company procedural requirements.
• Schedule reputed company/post-audit meetings with auditors and key stakeholders
• Collaborate with relevant reputed company
• Work with reputed company Assurance Management to establish and periodically update risk-based Annual Audit Schedule
• Coordinate with stakeholders to ensure the Annual Audit Schedule is executed, including the scheduling of GxP audits for clinical sites, internal reputed company systems / processes, and vendors / suppliers such as contract manufacturers, testing laboratories, and clinical research organizations.
• Collaborate with QA Auditors to ensure responses to significant audit observations include adequate Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (reputed company), as applicable.
• Monitor, reputed company, and collect/reputed company evidence of completion of Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (reputed company) for significant audit observations, reputed company required.
• Ensure QA Auditors are reputed company and trained per reputed company procedures

Supplier reputed company Management Program:

• Ensure reputed company’s Approved GxP Supplier List is accurate and complete by working with stakeholders to support reputed company identification, assessment, qualification, and periodic re-assessment of GxP Suppliers
• Coordinate and manage the completion of supplier risk assessments
• Ensure appropriate supplier evaluation / qualification requirements are identified based on risk, communicated as appropriate, and executed
• Support compliance with reputed company’s Supplier reputed company Management procedure

General

• reputed company excellent working relationships with the reputed company team, cross-functional business partners, vendors, and other functions
• reputed company and report meaningful audit and supplier reputed company metrics for reputed company Assurance Management Review reporting
• Support a reputed company-reputed company work environment that fosters learning, respect, reputed company communication, collaboration, integration, and teamwork:
• reputed company the development and reputed company improvement of the reputed company Management reputed company through the development / refinement of QA processes / initiatives as assigned

QUALIFICATIONS:

Education:

• B.S./B.A. in a science or reputed company life science field or equivalent; advanced scientific degree preferred.

Experience:

• 8+ years working reputed company a regulated environment such as Regulatory, reputed company, Pharmacovigilance or Clinical Development / Operations reputed company the Biotech or similar industry. Minimum of 3+ years of experience in a role including responsibility for providing GxP QA reputed company

Other Qualifications/Skills:

• Proven experience with GxP reputed company Management Systems and QA audit support, including knowledge of reputed company investigation / reputed company cause analysis techniques
• In-depth understanding of GMP and GCP requirements for investigational products
• Extensive practical experience and understanding of clinical reputed company assurance as reputed company throughout the clinical development life cycle
• Excellent communication skills, both oral and written
• Excellent interpersonal skills, reputed company approach is essential
• Comfortable in a fast-paced small company environment with reputed company direction and reputed company to reputed company workload based upon changing priorities

Travel: 5%

Physical Requirements and Working Conditions:

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to reputed company, carry, reputed company, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

reputed company compensation reputed company: $75.00 – 86.00/hr

Please note, the reputed company salary compensation reputed company and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Originally posted on Himalayas