The Supervisor, Quality Assurance – Systems is responsible for assuring that all operations at Catalent meet or exceed cGMP regulations and customer requirements. The Supervisor, Quality Assurance – Systems assures the quality of operations through the management and enhancement of the document management and supplier quality assurance systems.
The Supervisor, Quality Assurance – Systems is accountable for the daily operations of the supplier quality assurance program, including release of incoming materials, management of non-conformances and qualification of suppliers to support the GMP manufacturing operations.
In concert with Catalent's Patient First philosophy, the Supervisor, Quality Assurance – Systems position safeguards all systems, processes and actions to ensure regulatory compliance is met, which is essential in providing high quality drug products for our clients and their patients.
- Oversees the process of document control, including independently managing drafts, editing, approval, distribution and archiving, of all controlled documents.
- Maintains staff by recruiting, hiring, and training employees; developing personnel growth opportunities, supporting employee motivation and providing strategic alignment with Quality Assurance Department and site initiatives.
- Drives continuous improvement through leading cross function teams, to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvements.
- Maintains data integrity and ensure compliance with company SOP's, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.
- Maintains safe and healthy work environment by establishing and enforcing organization standards; adhering to legal regulations.
- Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 12 years' related technical experience OR 6 years' related experience with demonstrated career progression including leadership responsibilities.
- Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 14 years' related technical experience OR 8 years' related experience with demonstrated career progression including leadership responsibilities.
Catalent's standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Fast tracked career growth, with annual performance review and feedback process
- Competitive base salary with other compensation incentives including yearly incentive plan
- Medical, Dental, Vision, and 401K are all offered on day one of employment
- 19 days of Paid Time Off (PTO) + 7 paid holidays
- Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
- Defined career path and annual performance review and feedback process.