Head of Quality Cell Therapy Manufacturing Facility

Employer
Celgene
Location
Summit, NJ, US
Posted
Oct 09, 2018
Ref
1803523
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

Head of Quality Cell Therapy Manufacturing Facility
Summit, NJ

Job Summary

Celgene is seeking a Head of Quality at the Celgene Cell Therapy Manufacturing Facility in Summit NJ. This role will be responsible for leading the day-to-day Quality operations at the Summit Cell Therapy site including Quality Assurance Operations, Quality Systems and Compliance, and Quality Control. The role will also be a key contributor to the implementation and execution of Celgene's quality systems in preparation for commercialization of Celgene's Cell Therapy products. This includes but not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for quality principles and compliance within the Summit Cell Therapy Facility organization. This individual will be a member of the Summit Manufacturing Leadership Team in addition to the Global Cell Therapy Quality Leadership Team. This role is stationed in Summit NJ and reports to the Vice President, Global Cell Therapy Quality.

Job Responsibilities
  • Responsible for the Quality oversight of GMP operations at the Summit Cell Therapy manufacturing facility, and ensuring adherence to applicable GMP regulations and Celgene policies and procedures
  • Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products
  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations
  • Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel
  • Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, MS&T, to ensure the timely facility qualification and readiness for commercialization at the Summit facility
  • Lead the management review of quality compliance and operational KPIs at the Summit manufacturing facility; ensure timely mitigation of unfavorable trends
  • Lead the implementation of Celgene's Pre-license inspection readiness plan at the Summit facility
  • Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit facility
  • Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMEA, MHRA, etc.)
  • 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 annual operating budget
  • Represent and lead Summit Cell Therapy Quality in the development of corporate initiatives and planning
  • Travel Required: 5%


Qualifications and Education Requirements
  • BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions
  • Expertise in GMP compliance and global regulations
  • Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required
  • Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required
  • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
  • Background in Biologics or Cell Therapy Manufacturing is required
  • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control 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 senior 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.