Senior Manager, External QA, CAR-T
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.1. PURPOSE AND SCOPE OF POSITION:
This position provides quality oversight for contract manufacturing organizations used to manufacture, package, test and distribute Celgene products in accordance with Celgene policies, standards, procedures and international cGMP's. The incumbent will oversee multiple products at the Contract Service Provider (CSP) including intermediate, API and drug product.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- ·Must have expert GMP, Quality, and in-depth risk management knowledge.
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
- Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.
- Must drive development of technical or scientific initiatives by interdisciplinary teams.
- Must have strong authorship and be able to critically review investigations, quality agreements and risk assessment. Must be able to interpret results and generate conclusions consistent with Quality risk management principles.
- Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
- Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity.
- Understanding of assigned product and related processes and technologies
- Thorough knowledge of and competence in core quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
- Understanding of KPIs and operational metrics
- Working knowledge of US and International GMPs
- Third party QA experience is preferred
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met
- Ability to make independent and objective decisions and to work with minimal supervision
- Negotiation and persuasion skills are important
- Excellent verbal and written communication skills
- Knowledge of QP Processes for investigational and commercial materials
3. DUTIES AND RESPONSIBLITIES
Partner with Technical Operations to identify and qualify Contract Service Providers (CSP) for Celgene.
Serves as the Celgene Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CSP(s).
Oversee the Vendor's Quality Management to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specifications, and improvement projects are managed in a compliant and timely manner.
Negotiate and maintain the Quality Agreement to ensure compliance with their terms.
Partner with Technical Operations to assess overall product quality performance, including identifying any product-specific quality and compliance risks and develop a mitigation plans based on a risk based approach.
Ensure the Annual Product Review/Product Quality Review reflects the operations performed by the vendor and provides the appropriate level of detail and required trend analysis.
Final Quality Operations approver of all Celgene and CSP GMP documents that require Celgene Quality approval such as Investigations, Deviations, Change Controls, Validation documents, Specifications, Testing Methods, Complaints, Master Batch Records, etc.
- Responsible for final batch disposition decisions.
- Ensure PAI readiness of CSPs
- Develop Quality Metrics and assess the results in collaboration with Technical Operations, develop corrective actions with the vendor's Quality unit report results to management.
Actively participate in Celgene vendor audits and provide relevant information to the audit team.
Participate in the vendor Health Authority inspections and provide support as the Celgene representative.
Support new product launches
- Up to 20% travel may be required, when needed.
4. EDUCATION AND EXPERIENCE
BS or MS in related science and 8-10 years of experience in a pharmaceutical environment or other regulated industry.
5. WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
#LI-POSTCelgene 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.