Senior Manager, Quality Control Operations
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
Reporting to the Director, Quality Control Operations, the Senior Manager, QC Operations and Stability will perform quality control functions supporting drug substance, drug product and cell banks. This individual with collaborate with cross functional stakeholders and externally with contract manufacturing facilities.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
- Evaluate product stability data to establish and extend product shelf-life.
- Assure ongoing readiness for regulatory inspection; participate in audits and inspections.
- Create and improve procedures.
- Support Regulatory submissions (e.g, INDs, BLAs), coordinate data requests, compilation and management of externally generated data
- Ensures appropriate data integrity controls/ALCOA/data integrity issues for system requirements.
- Generation of Certificate of Analysis
- Serve as a technical lead for management of Quality Records: Global application of root cause, deviations, impact assessments, complex investigations in collaboration with other departments.
- Provide hands-on leadership for the QC Operations oversight of the group, data review, schedule and training.
- Provide oversight and support to contingent staff on site
Requirements:
- BS in Biology, Biochemistry, Chemistry or equivalent are of study/discipline
- 7+ years of GMP experience in Pharmaceutical Industry
- Experience in data management, LIMS experience preferred
- Organized and skilled in managing multiple responsibilities, priorities, tasks and projects simultaneously
- Strong interpersonal skills that include negotiation, active listening, and relationship management
- Comfortable with interfacing effectively across all levels and organizations
- Independently motivated and detail-oriented with good critical thinking, problem-solving ability, and analytical skills #LI-CS1 #LI-Onsite
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
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