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:
Responsible for Quality Assurance oversight of the analytical laboratory operations Laboratory Systems Management, Analytical Technical Services and Stability Services, for GMP commercial activities conducted at Celgene NJ sights and at Contract Service Providers/CMOs (contract labs)
DUTIES AND RESPONSIBILITIES
Developing laboratory policies and procedures based on regulations, industry guidelines and Celgene requirements
Develops and maintains the SOP and procedures that govern the Quality Operations - Analytical support function.
Generates and maintains Quality Agreements for external GMP testing facilities.
Oversee the lab operations of Contract Service Providers/CMOs and ensure compliance with cGMP.
Ensure that contract labs mange Change Controls, Deviations, CAPA, Test Methods, Specification and improvement projects in a compliant and timely manner.
Develops Quality metrics and assesses the results with CMO quality unit
Implements new policies/systems in keeping with constantly changing/emerging FDA/industry requirements.
Provides Quality Operations approval and/or SME input on critical change controls.
Assists Regulatory Affairs in the submission of NDAs and subsequent responses to deficiency letters.
Ensure management escalation and HA notification of critical lab deviations is timely and in accordance with relevant HA expectation.
Communicates to QPs of any deviations that may impact the relevant region.
Assures QA oversight meets or exceeds industry and FDA trends/expectations
FDA liaison during inspections related to CMO Analytical Laboratory issues.
Provide Quality Assurance support to laboratory function of Celgene affiliate as needed
Manage staff responsible for reviewing and approving, Laboratory Systems Management (LSM), Analytical Technical Services (ATS) and Validation related GMP documents including, but not limited to:
SOPs, Work Practices and associated Forms
Validation plans and protocols
IQ/OQ/PQ documents (equipment and software related)
User Requirements Specifications
Certificates of Analyses and Reference Standard Purity Statements
Analytical Protocols and Reports (validation, transfer etc)
Methods and Specifications
Change Requests and Change Controls
Deviations, Investigations and CAPAs.
Annual Equipment Review
Methods implemented by Contract Service Providers (CSP)s
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.
PREREQUISITES: BS/MS in scientific discipline with 8-10 years experience in FDA-regulated industry
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 cGMP in the pharmaceutical industry
Strong verbal and written communication skills
Exhibits excellent leadership and fosters teamwork to create an environment of support that leads to positive motivation and increase productivity of group personnel.
Ability to lead and work within a team setting
Management experience required
EDUCATION AND EXPERIENCE
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
BS/MS in analytical chemistry or related science.
At least 8 years experience in at an FDA regulated industry
Experience in both Quality Control (QC) and Quality Assurance (QA)
Third party/CMO oversight management experience is essential.
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.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.