Supervisor, Sterility Assurance and Compliance

**Department**:Quality

**Position Summary**

As Supervisor, Sterility Assurance and Compliance at CCRM, you are an experienced individual in Good Manufacturing Practices (GMP) manufacturing of regulated products. You are driven by the opportunity to enable clinical translation of cell and gene therapies. You are responsible for overseeing the quality management system and monitoring quality performance indicators. You are also responsible for continuously monitoring and ensuring overall compliance of activities carried out at the site. You will supervise and develop CCRM’s Compliance team to deliver on client demands, including fee-for-service work, contract manufacturing, access services, technology transfer, training, and technical and process development services to cell and gene therapy developers. You will provide technical expertise and be responsible for managing client audits, communicating with customers and leadership, and ensuring the high-quality delivery of contract services.

You will be a leader in understanding how to overcome compliance challenges for cell manufacturing and testing to enable life-saving advances in cell and gene therapies.

You will act as a champion for building a culture of quality across the organization.

**Responsibilities**
- Implements and maintains an external-facing quality management system, including materials management, vendor management and audits (internal, external and third-party).
- Implements a supplier audit program to support GMP operations.
- Leads the review and management of quality agreements and validation protocols for facility, equipment, computer systems and software.
- Institutes a system for approving deviation investigations and implementing corrective actions and preventative actions (CAPA) and change controls.
- Monitors and manages the CAPA system, including evaluating CAPA records for appropriate plans and actions, monitoring timely completion and evaluating CAPA effectiveness. Analyzes CAPA data and monitors for emerging trends.
- Leads the team in developing, drafting, reviewing and approving specific standard operating procedures (SOPs), specifications, manufacturing batch records and other documents in accordance with GMP regulations.
- Supervises the development and maintenance of the quality management system.
- Develops and maintains metrics and reporting tools to monitor and review compliance activities such as investigation and CAPA management at the site. Acts as lead to respond to issues and concerns in a manner consistent with quality and regulatory requirements.
- Performs trending and reporting of quality performance indicators to monitor the overall health of the quality system.
- Implements internal audits and audits for facilities and systems to ensure compliance with SOPs and GMP regulations.
- Supports hosting audits by clients and regulatory authorities.
- Provides necessary support during regulatory inspections, which may include providing pre-requested documents, performing key audit roles/functions and following up on audit observations related to compliance issues.
- Assists in the preparation of regulatory documents.
- Acts as an active member of the Quality and Compliance management team and helps support continuous quality improvements.
- Reviews the aseptic strategy policy for CCRM.
- Provides support in aseptic processing, contamination control program and risk mitigation.
- Reviews and approves sterility assurance SOPs, focusing on evolving regulatory requirements and phase-appropriate GMP requirements.
- Reviews the environmental monitoring program and identifies the deviations and trend reports from the documents.
- Reviews the aseptic gowning qualification program and maintenance of personnel qualification.
- Oversees sterility assurance for the quality management system, including validation master plan, equipment qualification and cleaning validation.
- Represents the Compliance and Sterility Assurance team during client audits.
- Ensures proactive performance management by implementing annual performance appraisals and career development plans for all department employees. Routinely works with direct and indirect reports to co-manage their career development.
- Represents CCRM and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, etc., and customer/supplier visits.
- Interfaces with academic and industry partners to ensure meaningful engagement and collaboration.
- Demonstrates CCRM’s values of purpose, integrity, excellence, accountability and collaboration, and motivates others to do the same.
- Evolves in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy industry and regenerative medicine field.

**Requirements**:

- A bachelor’s degree in science (microbiology, bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, chemistry, etc.).
- 8+ years of