QA manager

Job Overview:

Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill client and Fortrea requirements. Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA and C central planning system. Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure. Provide local leadership and/or line management as required. This role may be an Individual Contributor or have line management responsibilities.

Summary of Responsibilities:

• Auditing:
• Act as a Lead Auditor.
• Plan and conduct audits, as assigned, according to applicable SOP(s) and the global audit plan.
• Provide guidance to QA and C auditors and operational staff regarding GxP issues.
• Identify non-conformances with requirements and provide suitable recommendations.
• Ensure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management.
• Ensure suitable responses to CAPAs are provided by auditees within the agreed timeframe escalate to QA management where resolution of audit findings are inadequate.
• Follow up and closure of audits and CAPAs within agreed timeframe.
• Maintain all audit and CAPA tracking systems.
• Prepare overviews of audit findings for presentation to management.
• Serve as a backup auditor to other QA and C staff.
• Special Projects:
• Lead/participate in QA projects.
• Support special projects requiring QA input.
• Support QA initiatives associated with tracking, trending, and analysis of audit findings.
• Quality Assurance:
• Contribute to process improvement initiatives across organization.
• Provide support and direction to maintain global quality system to recognized standards.
• Participate in development of QA processes and SOPs.
• Support development of processes and SOPs by process owners outside QA.
• Liaison / Representation:
• Represent QA on project teams and other internal forums.
• Represent QA at client meetings and/or audits.
• Act as liaison with clients and/or their third-party auditors.
• Supervision and Management:
• Provide line management, if applicable.
• Business Development:
• Contribute to the preparation of Time and Cost Estimates as requested.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/college degree, BA/BS, or equivalent experience.
• Advanced degree (e.g., postgraduate qualification in quality assurance) or equivalent experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 3 Years experience in Clinical Quality Assurance, preferably with GCP experience.
• 5 Years experience in other professional roles within pharmaceutical/CRO environment.
• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process.
• Financial understanding of global clinical development budgets.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Knowledge of the drug development process from the perspective of a contract research organization.

Preferred Qualifications Include:

• University/college degree, BA/BS (life science preferred).

Physical Demands/Work Environment:

• Based in Fortrea offices, traveling to other Fortrea offices, sponsor premises, investigator sites, pharmacies, third party vendors and staying away from home when required.
• Due to the high travel requirement of the post, staff must be flexible in scheduling workload. Appropriate flexibility in working hours will be overseen by the line manager to compensate for time worked in excess of contracted hours.
• Travel Required 30% of time which will require an overnight stay. Travel is primarily Domestic or Regional.

Learn more about our EEO & Accommodations request here.