Director Quality Systems & Compliance

Summit, NJ, US
Oct 31, 2018
Required Education
Bachelors Degree
Position Type
Full time
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.

Director Quality Systems & Compliance

Travel Required: 5%

Location: Summit, NJ

Position Type: Full Time

Job Summary

Celgene is seeking a Director Quality Systems & Compliance at the Celgene Cell Therapy Manufacturing Facility in Summit NJ. This role will be responsible for implementing and managing the site Quality Systems, Training program, identifying and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and Celgene policies. This individual is also responsible for leading the site Quality Management Review program and reporting quality metrics and representing the site in the Global Quality Management Review team.

The Director Quality Systems and Compliance will be a key leader in the management team and a champion for quality principles and compliance within the Summit Cell Therapy organization.
This role is stationed in Summit NJ and reports to the Head of Quality Summit Cell Therapy Manufacturing Facility.

Job Responsibilities
  • Responsible for the overall site Quality Systems execution and management of deviations, CAPA, change control and risk management activities, ensuring adherence to applicable GMP regulations and Celgene policies and procedures
  • Collaborate with QA Operations and ensure the timely and compliant investigation of deviations and development of corresponding CAPAs
  • Responsible for management of site document control system and records management
  • Responsible for management of site GMP Training program, including but not limited to oversight of role base curricula development, approval of train-the-trainer program and training materials, management of training records and site level administration of the e-Learning Management system
  • Monitor the health of the site Quality System; lead site Quality Management Review Board and report site quality metrics to corporate functions as required
  • Oversee the implementation of an effective risk management program at the site
  • Develop and oversee the execution of site internal audit program (self-audit); host corporate and external audits , including regulatory inspections
  • Oversee the site preparation for regulatory inspections, and manage the regulatory inspection logistics
  • Provide leadership and build an exceptional team to manage the Quality Systems and Compliance functions, including hiring, mentoring and developing personnel
  • Collaborate with cross-functional partners and represent the Summit Cell Therapy user community in the Quality Systems governance, life-cycle management and continuous improvement initiatives
  • Develop departmental goals and ensure timely completion of all deliverables
  • Champion and foster a positive and quality compliance culture
  • Establish and effectively manage the Summit Cell Therapy Quality Systems & Compliance annual operating budget

Qualifications and Education Requirements
  • BS/MS in relevant Science or Engineering discipline and 10+ years of experience in managing Quality Systems and Compliance functions
  • Proven record with the successful implementation and management of the Quality System in a sterile or aseptic commercial manufacturing facility
  • Expertise in GMP compliance, Quality System and global GMP regulations; must also have strong knowledge and experience with Quality Risk Management
  • Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and timely mitigate unfavorable quality compliance trends
  • Background in Biologics or Cell Therapy Manufacturing is preferred
  • Demonstrated experience building and leading exceptional Quality teams is required
  • Experience in continuous improvement, operational excellence and six-sigma is desired
  • Demonstrated excellence in written and verbal communication
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment

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.