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 cGMP, Quality, and risk management knowledge.
- Must be able to critically interpret problems and effectively communicate in a productive manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be able to recognize and group technical/scientific attributes in potential situations or issues and drive science based decisions across the function.
- Must share information about current interpretations and application of regulatory expectations between the decision-maker and other stakeholders.
- Must have expert authorship in technical documents. Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles.
- Must have expert authorship in investigations, quality agreements, and risk assessments. Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.
- 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 understand the 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 international GMP requirements
- 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
3. DUTIES AND RESPONSIBILITIES
- 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 Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner.
- Responsible for the content of the Quality Agreement and ensures compliance.
- Partners with Technical Operations to assess overall product quality performance, including identifying any product-specific quality and compliance risks and develops a mitigation plans based on a risk based approach.
- Ensure the Annual Product Review/Product Quality Review reflect the operations performed by the vendor, provide the appropriate level of detail and required trend analysis.
- Final Quality Operations approver of all Vendor GMP documents that require Celgene Quality approval such as Investigations, Deviations, Change Controls, Validation documents, Specification, Testing Methods, etc.
- Develops Quality metrics, assesses the results in collaboration with Technical Operations, develops corrective actions with the vendor Quality unit and reports results to management.
- Active participate in the Celgene audit team and provides relevant information to the audit team .
- Participates in the vendor Health Authority inspections and provides support as the Celgene representative.
4. EDUCATION AND EXPERIENCE
Relevant college or university degree required; advanced degree preferred.
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.
6. DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidentalor secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.