Are you based on the East coast or willing to relocate?
Are you an experienced GCP/GLP professional who thrives in a fast-paced environment?
Are you an ambitious individual looking for forward-thinking, rapidly growing organisation?
Fraser Dove International is partnered exclusively with an ambitious Biotech organisation seeking an Associate Director of Quality Assurance to assist in creating a GCP/GLP/GVP Quality strategy.
Discover more about our Associate Director, Clinical Quality Assurance opportunity; it’s objectives, duties/responsibilities and the skills, experience, and competencies needed to succeed.
The Associate Director, QA will oversee R&D compliance programs (GCP/GLP/GVP). The individual will assist in creating the overall GCP/GLP/GVP Quality strategy along with the Head of the Clinical Quality Assurance team. This person will be responsible for ensuring that associated external and internal entities meet all regulatory requirements.
What you will do:
As the Associate Director, Clinical Quality Assurance, your duties and responsibilities will include:
- Assist in defining the Clinical Quality and Compliance vision and mindset of the company.
- Develop, implement and maintain QA systems and SOPs for GCP systems.
- Promote compliance within the company and represent QA, as required.
- Establish and enhance audit and inspection processes and procedures.
- Work with internal GCP customers and develop and execute strategic audit plans.
- Matrix manage projects, including teams of multifunctional personnel.
- Act as expert GCP consultant to groups within the organization.
- Help lead in inspections/audits, in agreement with QA management.
- Plan and conduct regulatory audits/mock inspections.
- Review and identify improvements that enhance the quality and clarity of audit reports.
- Assist QA management in the development and implementation of strategic procedures and working practices.
- Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories.
- Participate in budget forecasting, planning and tracking for QA.
- Establish and maintain quality metrics and reporting.
- Coordinate, develop, maintain and/or provide GCP training to personnel.
What you will bring:
These are the skills and experience you will need to succeed as the Associate Director, Clinical Quality Assurance:
- Extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharma, laboratory, or relevant area.
- Expertise in GCP regulations and guidance for FDA and International agencies including ICH guidelines.
- Excellent knowledge of, and working experience with, relevant national/international regulations.
- Experience with Microsoft based applications and ability to learn internal computer systems.
- Ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
- Provide leadership to teams and projects to aid in a successful conclusion.
- Effectively communicate situations/issues alongside potential recommendations.
- Excellent attention to detail, time management, and investigative skills.
- Excellent interpersonal, verbal, and written communication skills.
- Educated to degree level, preferably life science or equivalent qualification or clinical research experience.
- Bachelor’s degree in a science, technology or industry-related discipline, preferred.
What you will get:
A generous base salary along with perks and benefits to compliment.
- Performance bonus
- Long Term Incentives (LTI)
- Dental insurance
- Life insurance
- Private healthcare
- Generous holiday allowance
- Commuting expenses
- Relocation assistance
Got what it takes?
To apply for the Associate Director, Clinical Quality Assurance, click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.