The Sr. Associate II responsibilities will ensure that Quality systems supporting facility, equipment, automation and utilities within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards.
Responsibilities include, but are not limited to:
Review of GMP raw data and GMP documentation for compliance to applicable procedures as well as regulatory and corporate guidance documents, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, instrument & controls oversight, and support of investigations impacting the utilities, equipment and RTP site.
The position will assist in the development and implementation of Global Quality Systems, leading site and global initiatives, identify gaps in existing Quality systems and propose solutions to site management.
Provides oversight with respect to proper adherence to all regulatory licenses and regulations
Collaboratively interface with key Quality, Manufacturing, and Engineering customers to achieve site and company objectives
Support internal compliance audits; external inspections from regulating agencies, assess and approve discrepancies from site, corporate, and regulatory guidance.
Support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies.
Ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture.
Principal Accountabilities supporting Drug Substance & Drug Product site:
Oversight of the Change Control program at the Drug Substance & Drug Product campuses ensuring that the overall program health and metrics are maintained.
Develops and implements aspects of various Quality Systems/System Improvements, specifically Change Management.
Lead strategic Quality initiatives cross functionally and globally
Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval.
Oversight of facility and equipment controls and release during shutdown, construction, product changeover.
Provide cGMP guidance and quality support for Manufacturing Engineering and Automation on the floor issues, including assistance with deviation initiation and investigation.
Review of PM work orders and CM work orders as applicable to cGMP systems
Proactive identification and resolution of both technical and compliance issues/gaps
Performs QA review of alarm assessments for cGMP equipment
10+ years of Quality / Industry-related experience in the following disciplines:
Robust experience with Change Control program management
Subject matter expert for change management, Quality Risk Management and data integrity
GMP review of validation documentation and strong knowledge of equipment/facilities/utility /automation systems
Technical expertise in bulk drug substance biologics production or sterile parenteral & biologics fill/finish and visual inspection operations
Agency inspection experience
Previous experience with Quality Systems development
Knowledge of current global Regulatory Quality requirements
Bachelor's Degree in Engineering or related Life Science or Technical discipline