This position is responsible for Quality Assurance (QA) Specialist, primarily with QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management and providing a reliable source of information and accurate interpretation of quality, cGMP compliance requirements and quality systems, together with maintaining good working relationships with QA departments at contract facilities.

Note: Occasional travel may be required as part of this role

Responsibilities include, but are not limited to, the following:

* For the assigned products and area of Celgene Global Quality Operations and International Quality Operations:
* Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements.
This includes:
* Building and maintaining a good working relationship with the contractor
Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation, etc.
* Recommending quality related improvements to the contractor
* Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
* Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements

* Manage change control requests.
This includes, as necessary:
* Initiating and approval routing of change control requests
* Performing QA evaluation and endorsement/approval
* Review of associated contractor change control requests
* Monitoring progress of related action items
* Escalation of change controls as required
* Process product complaints. This includes, as necessary:
* Providing support for complaint investigations related to external vendors as required
* Approving complaint investigations where required
* Review, edit, negotiate improvements to, and approve contractor documentation, including:
* Process validation protocols and reports
* Transfer validation protocol and reports
* Investigations, Deviations, OOS records
* Lead review of Annual Product Quality Review reports, as necessary. Edit, and negotiate improvements to contractor supplied Annual Product Quality Review reports.
* Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
* Participate in self-inspections as appropriate
* Participate in external audits of contractor manufacturers and distributors as assigned
* Ensure logs, databases and files related to the product quality activities are maintained
* Performance of trend reviews and compilation of metrics
* For non-product related duties:
* Develop and/or maintain pharmaceutical quality systems, as assigned
* Author and/or revise standard operating procedures and associated work instructions, as assigned
* Review and provide recommendations on policies and standards, as assigned
* Support GMP/GDP site inspections, as assigned
* Maintain compliance with personal training requirements

Required Competencies

* In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
* Ability to assess the right balance between business targets and scientific and quality decisions
* Strong analytical and problem-solving skills
* Ability to build relationships, partnerships and influence and/ or enforce quality
decisions at external / internal sites as appropriate
* Good communication and organizational skills
* Project management skills
* Development, organization, and execution of the Pharmaceutical Quality System of BMS within the Global Quality Organization
* Must have computer proficiency

Required Qualification(s) and Desired Experience:

* BSc or equivalent in scientific discipline
* At least 5 years of experience in Quality Assurance in a pharmaceutical company.
* Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
* Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
* Experience in interacting with external manufacturers and supporting quality at external manufacturing sites

The Next Step for you:

Should this position be of interest to you please forward your CV to RAQUEL LOURENCO at Next Generation Recruitment via the Apply button. Next Generation are specialists in recruiting for roles in Data Science, Digital, Engineering & Life Sciences, IT, Supply Chain & Operation, Engineering and are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.