Title: Quality Validation Manager
Location: San Francisco, California
Summary: Focused on delivering high-quality biosimilar therapeutics, this rapidly growing organization a global leading biologics platform company aiming to become the next leading organization in the biosimilar market. With a team of industry veterans, the overall collective expertise in niche areas consisting of process science, analytical characterization, and regulatory development, gives the organization the ability to actively develop their own pipeline of immune-oncology branded products. As a result, individuals are able to join a collaborative organization with the stability of a large commercial biologics company combined with the exciting rapid innovation one would see in a small start- up organization.
- Process and Review Validation documents as well as approving plans, reports, and protocols in reference to both internal and external activities
- Develop and establish validation programs to display that regulatory expectations have been met, all while administering and maintaining quality driven agendas.
- To present oneself as the technical expert for Quality as well as supplying guidance and support of external validation activities to ensure that CMO's are meeting the organizations standards and expectations.
- Bolster the change control, investigations and technology change programs with respect to equipment upgrades, deviations, and/or corrective and preventative actions.
- Establishing and implementing the Validation Program with consideration and inclusion of Master Plans all while assisting in the identification, advancement, and utilization of new technologies.
An Ideal Candidate will have:
- A Bachelor's degree in a scientific related field with at least 5+ years of experience in the life science field as well as 5 years of experience with qualification and validation roles.
- Comprehensive understanding of Drug Substance, Drug Product and Aseptic Manufacturing along with insight in Pharmaceuticals and the ability to assess compliance risks.
- Strong Leadership, management, organizational and deductive reasoning skills required while working with and formulating high level performance teams.
- Working knowledge of Master Control and Microsoft Office including word and excel.
- Insurance, Health and wellness benefits include coverage with vision, dental, disability.
- FSA and HAS accounts as well as retiree health and medical plans.
- Pension, 401K and Retirement plans in place
- Stock purchase plan options upon employment
- Performance Bonus, Vacation and PTO with Paid Holidays.