QA (R&D) Associate Director – Biotech/Pharma
Company: Multinational biotech company
Start: ASAP (aim for 1st of March)
For a well-respected client we are searching for a QA Associate Director (R&D) with GLP/GCP experience. The ideal candidate has experience in small or medium sized biotech company where he/she has helped to build the quality systems and developed an understanding of early drug development.
Experience with compliance auditing and GLP is essential. Soft skill wise we need someone with a flexible and solutions-oriented way of thinking.
Our client is an international biotech company that is dedicated to bring innovative therapies to patients.
Purpose of the role
We seek an integrative, collaborative, and patient-centric thinker for a key role in Quality Assurance support of pre- and non-clinical development. In this position, you will design, implement, and manage risk-based Quality Systems to efficiently support in-house development laboratories supporting GLP and GCP studies. You will also provide quality and compliance leadership to internal teams, consultants, and external vendors.
- Provide R&D Quality Assurance support to bioanalytical assay development, execution, and transfer.
- Provide QA oversight of internal and contract laboratories supporting GLP and GCP studies.
- Collaborate with cross-functional teams to identify, prioritize, and remediate compliance gaps and risks.
- Develop and implement risk-based audit and oversight strategies for GLP and GCP laboratory vendors and internal processes.
- Manage routine audit conduct by external consultants
- Lead high-complexity and high-risk audits where representation is required.
- Lead cross-functional investigations, root cause analysis, and CAPA development for significant departures from GLP at vendors
- Collaborate with supported functions to develop and implement inspection readiness plans
- Lead quality and compliance awareness throughout the organization by example and by coordinating cross-functional training opportunities.
- Approximately 20% domestic and international travel required.
- S. Degree in biology, chemistry, or an allied health field with at least in 8 years in the pharmaceutical or biopharmaceutical industry.
- S. Degree in biology, chemistry, or an allied health field with at least 6 years in the pharmaceutical or biopharmaceutical industry.
- Expertise in application of global GLP standards is mandatory. Expertise in global GCP standards is desirable.
- A passion for bringing innovative therapies to patients with serious unmet medical needs.
- Experience with leading execution of risk-based quality and compliance strategies.
- Strong ability to prioritize and operate with a sense of urgency.
- Effective communication and interpersonal skills, including the ability to interact with all levels within the organization.
- Demonstrated ability to develop practical solutions in a dynamic and innovative environment.
- Exhibits integrity and commitment to high ethical and compliance standards
- A sense of humor
Are you interested in this position or do you want to know more about it? Do not hesitate to contact me by applying to this position!