- Support Quality Compliance activities associated with Commercial cGMP biologics drug substance operations through internal/regulatory body audits, document review and interactions with site personnel at Takeda Brooklyn Park site.
- Provide guidance to site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.
- Regularly work cross-functionally with other departments and may also interact with other Takeda sites and/or Brooklyn Park suppliers to ensure global compliance and consistency.
- Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
- Conduct analyses of manufacturing-related quality metrics to identify risks, improvement opportunities and/or compliance concerns. Drive resolutions to conclusion by supporting continuous improvement initiatives.
- Coordinate logistic activities related to the Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.
- Oversee any required corrective actions resulting from self-assessments or inspection readiness activities.
- Lead the Inspection Readiness team and support during all internal or regulatory audits/inspections of Quality & Operations departments.
- Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.
- Identify and escalate regulatory issues and trends pertinent to Takeda products and business to management, as appropriate.
- Provide pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).
- Receive overall project direction from management but completes work independently.
- Complete mandatory training within required timeframe.
- Additional tasks and duties as assigned.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s degree in Life Sciences and 5+ years experience in a regulated industry preferred.
- Master s degree in Life Sciences with 3+ years experience in a regulated industry a plus.
- Knowledge of cGMP regulations for US, EU and other markets.
- Must be detail-oriented and have effective time management skills.,.
- Excellent interpersonal skills and the ability to work effectively and efficiently in a team environment.
- Must be able to clearly and effectively present to all levels of the organization
- Excellent organizational skills
- Proficientcomputer, verbal and written communication skills.
- Strong problem solving and data analysis skills.
- Drives results
- In general, the position requires a combination of sedentary work and walking around the facility.
- Frequent wrist and hand motion (e.g. typing, writing).
- May frequently lift up to 10 pounds (i.e. binders, files)
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately 0-5% travel.
Brooklyn Park, MN