Senior Manager, Clinical Quality Assurance Compliance - REMOTE

Proclinical is seeking a remote Senior Manager of Clinical Quality Assurance Compliance with a biopharmaceutical company located near Gaithersburg, MD.

Job Responsibilities:

• Participates in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management
• Works with internal and external GCP/PV entities and develop and execute strategic audit plans.
• Supports the development and/or review of GCP/PV audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
• Supports the development, implementation and maintenance of CQA systems and SOPs for GCP/PV systems
• Leads internal and external audits of the various quality elements to ensure compliance to GCP/PV/GCLP regulatory commitments and requirements, industry best practices and guidance
• Act as a contact with members of Regulatory Authorities and / or vendors; assist and lead inspections / audits, in agreement with QA management.
• Participates in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
• Evaluates and presents solutions on complex issues with minimal input from senior staff
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.
• Reviews, tracks and/or trends routine quality data. Reports adverse trends to management with remediation plan.
• Performs final quality review/assessment for new Clinical Vendors/CROs
• Trains and mentors junior staff
• Independently writes and implements controlled documents (i.e., SOPs, Policies, Audit reports) which may entail significant system changes
• Stays current with changes to current GCP/PV/GCLP regulations, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies so that NVAX's compliance policies are current and effective.

Skills and Requirements:

• Bachelor's degree in biological science is required.
• 8+ years' experience in GXP pharmaceuticals, biologics and/or vaccine clinical research.
• 5+ years industry experience in an auditing role
• CQA/RAPS or other audit certification is highly preferred.
• Knowledgeable in principles and current GCP/PV/GCLP in a clinical development to commercial application setting.
• Excellent multi-tasking, analytical, organizational and teamwork skills.
• Ability to troubleshoot, identify root cause and systematically resolve problems.
• Ability to communicate clearly and effectively with all levels of the organization.
• Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.
• Individual must be willing to travel domestically and internationally (30-50%), as needed.

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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