This person is responsible for managing the quality interface with manufacturing and testing partners for clinical small and/or large molecules, early to late phase for API / Drug Substance / bulk drug products / drug products and finished products. This person will be the primary quality contact for onboarding new clinical assets, product / process transfer, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management. This person will lead and/or support continuous improvement initiatives related to Biogen's QMS and procedures for CMO and partner oversight.
This position collaborates with internal and external functions such as External Manufacturing Operations, Clinical Supply Chain, Label Development, Planning & Logistics, Regulatory Affairs, Product Development Quality and Technical Development to ensure compliance with cGMP regulations and Biogen QMS.
Success in the role requires a strong knowledge in the application of phase appropriate, risk-based quality principles. Success in this role requires an ability to develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.
Ensure efficient and effective use of time to support priorities and drive for results.
Oversee quality aspects of GMP activities for clinical product manufactured, stored, and distributed, through Biogen's CMO and investigator site network. Activities include product disposition, quality support manufacturing operations, exceptions management, change control, risk management, technology transfer and validation.
Provide Quality expertise to influence tactical decisions needed to manufacture and disposition product in a compliant manner to GMPs.
Support Biogen initiatives to improve systems/processes in Global Quality with a goal of compliance, efficiency and standardization.
Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections.
Perform tasks and makes decision consistent with cGMPs, GDPs and Biogen's quality governance
Draft and negotiate Quality Agreements with CMO's
Collect and perform trend analysis for KPIs.
Additional duties as assigned.
Minimum of 5 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 5 years in clinical and or commercial quality operations.
Experience in quality operations as it relates to unit operations for the manufacture of either one or more of the following modalities: Parenteral, Oral Solid Dosage Form, Gene Therapy, ASOs.
Experience working with third-party GMP vendors.
Comprehensive knowledge of GMP and GDP regulations and subsequent applications to pharmaceutical drug manufacturing, and or packaging and distribution.
Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
Experience in contributing to regulatory filings and inspections preferred.
BS degree in life sciences, engineering or related field preferred