Sr Manager Clinical Quality Assurance - GCP

Recruiter: Spencer Gregory Hale

Clinical Quality Assurance Manager

About the role:

The Clinical Quality Manager will oversee the global conduct of clinical process and vendor audits. They will lead a team of Clinical Quality Specialists to assure clinical research activities conform to federal and international regulations and BSC procedures and expectations.

This position offers the successful candidate the opportunity to interface with a wide variety of global and divisionally aligned stakeholders to assure quality throughout the clinical product lifecycle. They will influence and assure conformance to Global Quality policies and procedures and work closely with Quality Leadership, Global Clinical Operations, Divisional Clinical Leadership, Clinical Quality Community, Clinical Sourcing and External Suppliers.

This is a great opportunity to lead global audit team.

Your Responsibilities

This position is responsible for the management of the Clinical Quality Assurance Center of Excellence audit program in line with strategies and goals set by global CQA management.

The Clinical Quality Center of Excellence Manager will provide leadership and direction to his/her team, working in close partnership with Divisional Clinical Quality Management, Global Clinical Operations, Divisional Clinical Leadership, Clinical Sourcing and Clinical Quality Specialists.

• Oversees management of the global clinical audit program for vendor and process audits across all clinical divisions.
• Collaborates with clinical quality management, global clinical operations and divisional clinical teams to understand needs, identify key areas of regulatory risk and establish audit priorities.
• Participates in the development, implementation, and maintenance of global quality systems.
• Analyzes audit findings for trends and provides clinical management with regular reports.
• Identifies ways to improve compliance with regulations and BSC policies and procedures.
• Participates, Leads or Coordinates quality projects as needed to support continuous quality improvements.
• Provides data for, and participates in, management reviews as applicable.
• As needed, assist with internal and external audits (internal systems, trial master file, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
• Reviews and approves audit reports for accuracy and consistency.
• Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
• Provides input to training function and, where appropriate, gives training on issues identified during audits.
• Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices.
• Keeps abreast of regulatory requirements, and updates senior management on the possible ramifications of regulatory changes.
• Develops department plans and budgets, and monitors spending.
• Determines appropriate staff levels, schedules and resources.
• Recruits, trains, supports, and develops Clinical Quality Assurance staff (Auditors and Specialists).
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

What we’re looking for in you:

Minimum Qualifications:

• Bachelor's degree
• 5+ years Clinical QA compliance/auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines and or equivalent relevant experience.
• Demonstrated capability in collaborating, partnering, and influencing across functions/teams
• High degree of integrity, professionalism, and ability to establish credibility
• Management experience preferred
• Ability to travel
• Medical device experience desired
• Experience in a hospital setting desired

Requisition ID: 561746