Sr. Manager, Development Vendor Quality Management
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 position provides Quality oversight for the selection of contract manufacturing organizations used for the manufacture, packaging, testing and distribution of Clinical Supplies in accordance with Celgene policies, procedures and GMPs. The incumbent will cover multiple products at the Contract Service Provider (CSPs) and will report to the Executive Director of New Product Global Quality Assurance.
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, interpret results, and generate technical 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.
- Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful NDA approval.
- Good understanding of the GMPs as related to Clinical Manufacturing.
- Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies.
- Knowledge of required QP processes for Investigational Materials and expectations for International markets.
- Good Knowledge of CMC Regulatory affairs.
DUTIES AND RESPONSIBILITIES
- Partner with Technical Operations to identify and qualify manufacturing facilities for the Manufacture, Packaging and testing of Clinical Products.
- Serves as the Celgene Quality single point of contact for the assigned CSPs with responsibility for Quality and Compliance performance.
- Oversee the Vendor Quality Management Systems to ensure Complaints, Deviations, Stability and CAPA are managed in a compliant and timely manner.
- Oversees vendor change control process and ensures that Celgene products are manufactured in full compliance with all applicable regulations.
- Partners with Technical Operations to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
- Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.
- Develop Quality metrics as part of a balanced scorecard to assess ongoing monthly performance.
- Final Quality approver for all GMP documentation associated with Batch Records, Investigation Protocols etc.
- Responsible for final Batch Disposition decisions.
- Participates in Celgene Corporate Vendor Audits
EDUCATION AND EXPERIENCE
- BS/MS in a Scientific discipline, preferably in Chemistry or Pharmacy. 5 years of experience in relevant Pharmaceutical industry and role.
- Hands on CMC experience of clinical manufacturing. Periods spent in Clinical manufacturing operations would be considered advantageous.
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.