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Beschrijving vacature

The Senior Compliance Manager is responsible for mentoring and coaching compliance managers, creating/executing the vision, strategy & objectives for the GCP Compliance group, ensuring proactive compliance and inspection readiness are integrated into planning and execution of clinical trials and supporting audit/regulatory inspection(s).

The Senior Compliance Manger provides guidance to functional/clinical trial and program teams on Clinical Trial Quality Risk Management (CTQRM) and GCP related activities/issues.



Key responsibilities:

• Provide coaching, guidance, and mentorship to compliance managers

• Support to create the vision, strategy & objectives for GCP Compliance group and independently develop and execute initiatives & activities to deliver against defined vision & objectives

• Operational oversight of outsourced monitoring activities, including CRO/site oversight visits as a study compliance manager to ensure proactive risk & compliance activities are integrated into planning and execution of assigned clinical trial(s)

• Identify and anticipate quality issue trends and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion

• Provide support and guidance to functional/clinical trial teams in drafting responses to address audit/inspection findings

• Lead/support inspection readiness activities in close collaboration with Clinical Quality Assurance and ensure clinical trial team members are trained and prepared for regulatory inspections

• Conduct pre-inspection visits at investigational sites/third party vendors to support inspection readiness activities

• Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams.

• Maintain or update Standard Operating Procedures (SOPs), Working Practices (WPs) and Policy Documents in the area of compliance

Functievereisten

Bachelor’s degree or equivalent qualification in life science/healthcare, Master's degree is preferred

• At least 8 years clinical/industry/health authority experience, including at least 3 years with focus on quality and compliance (GCP auditor background preferred)

• In-depth knowledge of current regulatory and ICH GCP requirements. Strong experience of CAPA management, risk management and audits/regulatory inspections (e.g. FDA, EMEA)

• Experience in contributing to or authoring Standard Operating Procedures (SOPs), Working Practices (WPs) and job aids.

• Experience leading or participating in process improvement initiatives.

• Strong interpersonal, problem-solving, negotiation and conflict resolution skills

• Strong project management and organizational skills

• Very good written and verbal communication

• Effective in establishing and maintaining good collaborations across functions, business units and external partners

• Has a growth mindset

• Willing to travel (approximately 30%)

 

Functiebeschrijving
Beroepsveld:
Work experience:
Work experience is required
Duur van de werkervaring:
Between 2 and 5 years
Taalvaardigheden:
  • English
  • Fluent
Salaris van/tot:
Not provided
Date of expiry:

Over het bedrijf

As a leading personnel service agency in the areas of IT, engineering and life sciences, GULP brings companies and highly qualified experts together: Freelancers in projects, employees via temporary assignments to interesting companies or employees in permanent employment. In order to meet the changing requirements of customers and candidates, GULP offers a wide range of… Meer informatie