Director Gcp Compliance Europe
vor 2 Wochen
General Description:
The Director GCP Compliance Europe provides quality guidance, expertise and leadership to the regional Clinical Operations Europe GCP compliance team. The Director GCP Compliance Europe collaborates effectively with stakeholders within the region Europe as well as with global
stakeholders including the Global Clinical Operations Compliance Lead / Global Clinical Operations Excellence Head to ensure compliance-related needs of the business are met. Establishes measures to reduce compliance risks and enhance successful clinical trial conduct in the region.
Responsibilities - may include, but not be limited to:
- Provides team leadership, including guidance, oversight and GCP expertise.
- Fosters a collaborative working relationship with key stakeholders (e.g. regional study team members, global clinical operations compliance team members,..), to enable timely identification of potential problems, to ensure proper root cause assessments and corrective and preventative actions are in place.
- Supports regional compliance team through guidance in drafting responses and corrective and preventative action plans to internal/external audits and externa inspections as required.
- Identifies potential compliance matters and drives development and implementation of methods for improvement and resolution.
- Identifies trends in quality events for the region and shares these with the global compliance team as required.
- Provides expertise and guidance on initiatives involving processes and systems intended for use in clinical trials to ensure compliance with ICH GCP and any local regulations.
- Leads the development of a GCP inspection readiness programme at a regional level in alignment with global inspection readiness activities.
- Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
- Liaises with site oversight managers and global/regional study leads to provide input into quality oversight visit planning
Supervisory Responsibilities:
- Oversees the work of direct/indirect reports to ensure on-time, on-target and within budget results.
- Conduct regular 1:1 meetings and any other staff meetings incl mid-year and year end performance appraisals for direct reports which includes providing constructive feedback. Engages in career development planning for direct reports.
Education Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline
General Requirements:
- Minimum of 10 years progressive experience in the biotech/ pharmaceutical sector, with minimum of 6-8 years in GCP-related discipline/quality assurance role
- Solid leadership and demonstrated experience with strategic planning, prioritizing and management of initiatives and projects
- Exercises sound judgement and discretion in matters of significance
- Has excellent working knowledge of ICH/GCP, local regulations, SOPs and Clinical Operations Work Instructions and strong aptitude to learn about evolving regulations
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Excellent interpersonal skills, strong organizational skills and ability to influence and lead both with and without authority in a matrix organization
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications:
- Strong written and verbal communication skills
Travel: up to 10-15%
Competencies:
Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.
Planning/Organizing - Able to prioritize and plan work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long ho
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