Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
PURPOSE AND SCOPE OF POSITION:
The incumbent will assist in supporting CART teams. He/she will support batch record reviews as required. Experience in reviewing batch records to ensure the records meet cGMPs and submission requirements for Cell Drugs is highly desirable. The QA Manager, CART will also have additional responsibilities to ensure that Global Quality Operations maintains compliance in assigned responsibilities that include but are not limited to, reviewing process/method validation document, authoring quality system documents, managing deviations & product complaints and their investigations. The role will be responsible for Quality oversight of external Contract Service Providers globally.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- BS/MS in a relevant scientific discipline.
- 3 plus years of experience within QA functions in biopharmaceutical industry, knowledge of parenteral, sterile products or biologics manufacturing.
- Thorough knowledge of cGMP in the pharma/Biotech industry. Good understanding of cell drug development process.
- Knowledge and applicable experience with batch record review with strong emphasis on Biologics, Cell Drug Batch Records, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer.
- Partner with early and late stage CART teams to qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical product.
- Partners with Quality Ops to ensure Quality Agreements are in place for Clinical/Commercial Manufacturing, Testing and Supply.
- Responsible for change control management to include impact assessments, tracking and implementation.
- Must have strong interpersonal and communication skills, be a team player
DUTIES AND RESPONSIBILITIES:
- Supports Batch Record Review Function: Supports batch record review of CART products. Provides input on product disposition. Establishes positive relationships and interfaces with contract manufacturers and testing laboratories to communicate and promptly resolve quality issues. May represent QA on assigned project and product teams. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
- Perform GMP Document Review Function: (and may approve as required) SOPs, qualification and validation documents, technology transfer documents, analytical data and CMC sections prior to submission to regulatory bodies. Notifies senior management regarding quality issues as required by site procedures and prepares reports as requested. Tracks and reports performance metrics as required.
- Compliance Systems: Implements and maintains the activities for batch record review, SOP review, contractor management, qualification/validation review, and technology transfer, in compliance with cGMPs, SOPs, good documentation practices and in accordance with corporate, regulatory and project timeline expectations.
- Vendor Contacts: Communicates as required, with outsourced manufacturing, packaging/labeling and/or testing service providers regarding quality assurance issues noted during reviews.
- Communications: Proactively communicates, works with and provides timely services to staff and internal colleagues in QA, QC, AR&D, Investigational Materials Supply Chain, Information Systems, Metrology, Facilities and Training groups.
- Human Resources: Ability to function in a fast-paced environment and anticipate/adapt to changing needs and priorities. Consistently meets performance objectives. May be asked to assist in the evaluation of prospective employees for the quality assurance department.
EDUCATION AND EXPERIENCE:
- Minimum of a Bachelor’s degree in a relevant scientific discipline.
- Three plus years of Quality experience in the biopharmaceutical industry with knowledge of parenteral, sterile products or biologics manufacturing.
- Experience in Cellular Therapy preferred.
WORKING CONDITIONS: (US Only):
- Work is performed in a typical office environment, with standard office equipment available and used.
- Flexibility to travel up to 15% of the time is required.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.