This leadership position is responsible for developing, executing and managing the GCP Compliance program. It requires strong judgment skills and business acumen since the successful management of GCP Compliance will be achieved by building and maintaining strong relationships with multiple internal and external team members and cross functional groups. This position will be also responsible for identifying regulatory compliance risks and related issues, both preventatively and as they occur, and works in partnership with the Development Sciences organization to develop the optimal resolution plan. This individual is an active participant and key point of contact in project teams and sub-teams.
Strong knowledge of global GCP Regulations, and excellent communication and organizational skills are required. In order for the candidate to be successful in this position, the candidate must possess dynamic interpersonal and teamwork skills.
Manage, develop, and train the GCP Compliance personnel.
Ensure the integrity and quality of clinical data by overseeing all routine and directed; internal and external; domestic and international GCP audits and quality reviews.
Promote continuous improvements in quality systems and department infrastructure.
Act as a subject matter expert and provide GCP guidance to internal departments for all phases of clinical development.
Report significant and/or serious ongoing quality deficiencies to senior/executive management; either by formal or informal presentations and corrective and preventive action plans.
Provide leadership and manage GCP regulatory inspections globally and oversee the development and tracking of GCP regulatory commitments.
Keep abreast of changes in regulations and enforcement action and make recommendations for changes to policies and practices as needed.
Provide internal and external GCP training.
REQUIREMENTS / QUALIFICATIONS:
12+ years of experience in the Pharmaceutical or Biotechnology industry.
Minimum of 5+ years supervisory/management experience with 8+ years actively participating in Clinical Quality Assurance or GCP Compliance.
Current knowledge of FDA, EU, MHRA, Canadian, ICH, and other international GCP regulatory requirements.
Ability to work within a team oriented environment.
Ability to identify, interpret and communicate business risks.
Ability to lead, coach and motivate a specialized compliance team.
Detail oriented, with excellent oral and written communication skills.
Experience in developing, writing and implementing SOPs