AT ATHERSYS: Our people make the difference. We owe our success to the passionate, driven and growth-oriented people who have chosen to align their careers with our mission, “Committed to developing therapies to extend and enhance the quality of human life.”
WE ARE SEEKING: A Senior Director, Analytics and Quality Control. The Sr. Director, Analytics & Quality Control is responsible for managing the development and implementation of Quality Control Systems across Athersys and ensuring oversight and execution of all aspects of GMP/GLP/GCP related analytical testing. This includes the establishment of policies, procedures, guidelines, training, and other tools required for deployment. In addition, this position will collaborate with internal and external stakeholders to ensure method transfers, method validation, specification setting, and QC data integrity is established and maintained for late phase clinical and commercial programs.
- Create and establish overall QC strategy, controls, policies, procedures, and/or guidance documents to define and align the operations of all Quality Control activities globally for internal and external testing activities.
- Develop raw material testing & product release testing capabilities & lead execution of such
- Partner with the Regulatory, R&D, and QA functions to develop the Athersys assay strategy (particularly Athersys developed assays)
- Lead the organization through method transfers and analytical method validations for late phase and commercial testing and ensuring QC data integrity, including QC review and approval of documents.
- Build, lead and manage Analytical & QC team.
- Support the automation of data gathering, processing and information management in support of Quality compliance, operational KPIs trending and issuance of periodic trending reports.
- Drive quality control continuous improvement initiatives to enhance productivity and efficiency of QC operations.
- Support the organization as needed in interactions with other key functional units as well as with external contract testing labs.
- Develop and implement testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and documents that support the Quality Management System.
Education / Experience
- Bachelor's Degree in a science or health care field with a preferred focus on chemistry, biochemistry or microbiology or a related field of study
- 10 - 15 years of experience in biotech and/or pharmaceutical QC
- Strong strategic understanding and working knowledge of Quality Management Systems and how those systems are implemented to meet regulatory requirements
- Exceptional customer interface skills are required
Knowledge / Skills
- Demonstrated GMP industry experience & leadership in Quality & Compliance discipline.
- In-depth knowledge of global pharmaceutical authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective procedures/policies.
- Experience performing audits and hosting regulatory inspections.
- Excellent facilitation and project management skills, with strong verbal and written communication skills.
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities, effective time management.
Athersys is an equal opportunity employer. Qualified applicants are considered for all positions without regard to age, race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other status protected by applicable law.