Global Quality Assurance Auditor, Pharmacovigilance
About The Position
This role provides quality assurance auditing for the Pharmaceutical Diagnostics (PDx) business, with a focus on Pharmacovigilance (PV) and Global Compliance support for GMP manufacturing sites and PV-related functions. The auditor performs audits on behalf of CQA and shares insights and industry trends to support continued compliance and early identification of improvement opportunities. The role analyzes audit findings and trends, supports compliance assessments within PV QA, and monitors changes to regulations and guidelines. It provides QA oversight for updates to operating procedures, risk assessments, and change controls related to process changes and productivity or efficiency initiatives. The position also supports regulatory inspections, customer audits, vendor qualification and surveillance, quality system improvements, CAPA, and quality issue management.
Requirements
- Bachelor's degree from an accredited university or college, or a high school diploma/GED with at least 8 years of pharmaceutical industry experience.
- At least 6 years of experience in the pharmaceutical industry.
- Previous auditing experience.
- Experience interfacing with global regulatory agencies.
- Ability to comprehend and communicate key regulatory requirements and expectations.
- Collaboration, negotiation, and conflict-resolution skills.
- Knowledge of GPvP, cGMP, and GDP.
Nice To Haves
- Strong oral and written communication skills.
- Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, market, and execute programs.
- Established project management skills.
- Demonstrated experience applying classic Quality tools.
- Experience interfacing with global regulatory agencies.
- Ability to act as a change agent with energy, passion, and enthusiasm to drive change.
- Demonstrated effective interpersonal, teamwork, and networking skills.
- Ability to influence, determine a position, and argue it effectively within the business context.
Responsibilities
- Support the planning, preparation, and execution of internal and external audits for QRA.
- Ensure identified actions and observations appropriately remediate deficiencies, are completed on time, and are reviewed for effectiveness.
- Work with customers to conduct risk analyses of systems and processes and propose process or functional audits.
- Support regulatory inspections and customer audits as a functional QA subject matter expert.
- Conduct trend analysis of audit and other quality-related data and provide findings to internal and external stakeholders as agreed.
- Assure completion and documentation of vendor qualification and surveillance activities according to global and functional procedures.
- Participate in quality management system improvements.
- Guide and ensure CAPAs capture risk assessments, effective corrective and preventive actions, and required evidence.
- Perform QA approvals of Quality Event records.
- Stay current with guidelines from MHRA, FDA, EMEA, and other regulatory bodies; monitor legislation, implement changes, and inform the company of relevant updates.
- Provide Quality Assurance support, guidance, and management of assigned Quality Issues.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life insurance
- Disability insurance
- Accident insurance
- Tuition reimbursement
- Potential performance-based incentive compensation, including cash bonuses and/or long-term incentives
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What This Job Offers
Job Type
Full-time
Career Level
Senior
