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:
This position provides quality oversight for CSPs used to manufacture, package and test Celgene commercial biological products in accordance with Celgene policies, standards, procedures and international cGMP’s. The incumbent will oversee multiple CSPs including Drug Substance CMOs, Drug Product CMOs and external labs used for the manufacture, package and test of assigned biological products. To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to Celgene stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring quality system documents.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA and EU regulatory requirements, ICH guidelines.
- Good knowledge of biologics manufacturing processes and testing. Knowledge of proteins / monoclonal antibodies manufacturing processes and testing a plus.
- Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes and lyophilization a plus.
- In-depth risk management knowledge.
- Experience in vendors Quality oversight.
- Thorough knowledge of and competence in core quality processes - including change control, product complaints, deviations/OOS, CAPA management, investigations, APR-PQR.
- Excellent investigational and QA problem solving skills – e.g.
- Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
- 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 have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Analytical mindset – e.g.
- Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions.
- Able to recognize quality risks and develop contingency plans.
- Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures and tools.
- Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
- Quality performance / continuous improvement oriented – e.g.
- Able to create and maintain meaningful metrics for assigned activities.
- Able to recognize trends in product data and results.
- Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
- Good understanding of batch disposition principles, aligned with QP concept and associated duties including liaison with Health Authorities.
- Skilled in planning and organizing, building relationships, innovation management and resource allocation.
- Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
- Team spirit. Action-oriented and customer-focused.
- Negotiation and persuasion skills.
- Good knowledge of most common office software (Microsoft Office).
- Good verbal and written communication skills in English a must.
EDUCATION AND EXPERIENCE
- BS or MS or equivalent education in Science, or related fields.
- Minimum 10-12 years of experience in a pharmaceutical/ biopharmaceutical environment including previous QA experience – e.g. QA compliance role, vendor oversight, batch record review, lot disposition. Team management experience a plus.
DUTIES AND RESPONSIBILITIES
The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
- Quality oversight of the activities and services provided by the assigned CSPs – e.g.
- Serves as the Celgene QA single point of contact / VQM role.
- Support Quality risk assessments.
- Create / negotiate and maintain Quality Agreements.
- Review / approve relevant GMP documents to enable the performance of Celgene activities at the CSP. This includes, but is not limited to review / approval of product relevant validation and transfer documentation, Master Batch Records, Analytical Methods, Specifications, etc.
- Work closely with the CSP and involved SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented per Celgene procedures.
- Evaluate and communicate CSP quality related changes, ensuring assessment per Celgene change control procedures and documented in a timely fashion.
- Ensure that batch records and CSP relevant release documentation is made available
- in a timely manner to batch review functions / batch disposition functions or QPs; perform CSP batch record and CSP release documentation review as per needs.
- Collect APR-PQR related information and data from CSP per Celgene requirements.
- Participate in Celgene audits at CSPs, as needed.
- Coordinate the required support for Health Authority inspections of a CSP and participation in the inspection, as needed. Follow up on observations involving Celgene products.
- Support CSP periodic maintenance assessment.
- Liaison with CSP for batch review qualification process initiation and maintenance.
- Measure CSP quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with CSP to define possible areas for improvement and associated implementation plan.
- Collect CSP quality documentation necessary to support regulatory submissions.
- Hold appropriate periodic quality meetings with CSP representatives.
- Hold or actively participate in joint periodic meetings with CSP and stakeholders.
- Oversee vendors Quality Management system to ensure associated elements – e.g. Change Controls, deviations, complaints, CAPA, Test Methods, Specifications - are managed in a compliant and timely manner.
- Review and approve product artworks as appropriate.
- Contribute to Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
- Partner with Biologics stakeholders to assess overall vendor performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk based approach.
- Provide timely support and necessary information to QA colleagues, VQMs, QPs and Quality Management as required.
- Act as representation for Quality Operations and Compliance Management as required.
- Provide timely quality support to Celgene stakeholders and SMEs per project plans for regulatory submissions, new product launches, labeling changes and alternate CMOs related topics.
- Author necessary quality system documents; review and update procedures for Celgene Quality Management System per process ownerships.
- Support Health Authority inspections and audits of the site, act as QA representative (SME) for functional area relevant topics.
- Participate as QA representative to internal work streams, projects and improvement initiatives.
- Performs other tasks as assigned
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 incidental or 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.