Job Detail

Req #: 1902406


Location: Boudry, Neuchatel, Switzerland


Job Category: Quality


Work Location: Route de Perreux 1 2017


Organization: Quality Operations


Employee Status: Full-time


Job Type: Regular

At Celgene we are committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first.  Celgene’s team in Broudry are made up of passionate, talented people who contribute every day to achieving our mission of putting patients first with industry-leading programs.

To continue this important work, we are recruiting a Manager, QA operations to join our team.

Objectives of this Role

You are committed to actively support Celgene International manufacturing site and other departments to ensure cGMP compliant processes on the Boudry manufacturing site.
You are responsible for quality assurance (QA) involved primarily with the review of executed batch records for the release of bulk product, including management of product deviations/OOSs and related CAPAs, as well as validation and qualification activities QA oversight.
you will acts as QA Operations team leader related to bulk production and QC activities. In collaboration with the Director, you will provide leadership and performance driving to the QA Operations team and responsible for the supervision and monitoring of the processes under your ownership.
The activities include responsibility for various further activities as: release of raw materials for production, risk assessments, support of health authority’s inspections and corporate audits for preparation and as SME, oversight of maintenance interventions, annual QC qualification, as well as QA representative in different projects like product introduction, continuous improvement, …

What great looks like in this role
As a member of the Quality Operations team, you will be working closely with the Director, QA Operations to identify and handle process quality and cGMP compliance related issues and escalate them as appropriate.
It is expected that you have an active role in reviewing processes outside your direct scope of work and provide suggestions for improvements.
You are also responsible to oversee and manage the team reporting to you, including recruitment, performance review and development, as well as planning and follow-up on ongoing activities.

Knowledge and skills required ​

• Minimum 5-7 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.


• Proven coaching and people management skills with previous experience in line management.


• BS or MSc in science or related field, or equivalent degree/experience in a relevant discipline.


• Thorough understanding of cGMPs and regulatory requirements.


• Excellent understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.


• Excellent interpersonal, collaborative and organizational skills.


• Works independently, authority to make daily and non-routine decisions.


• Ability to focus attention to details.


• Very good written & oral communication skills in French and English, internally within the function and externally with cross-functional teams, at site and global level.


• Excellent investigational skills and QA problem-solving skills. Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.


• Recognized Subject Matter Expert (SME) within the group, provides guidance to other employees.


• Able to critically review reports effectively inputting quality risk management principles.


• Drives continuous improvement.


• Knowledge of most common office software (Microsoft Office).

Daily and Monthly Responsibilities

• Responsible with your team for batch record and analytical data review of bulk product and preparation for release, including electronic QA checklist in Oracle (MES), according to planned dates and market needs.


• Responsible for authorization in production, including status change in Oracle, of raw materials (API and excipients).


• Review and approve the Master Batch records (MBR) and associated production documentation in collaboration with internal or external partners as appropriate.


• Support and coordinate with your team the deviations and CAPA process for bulk production and QC activities related to bulk product and raw materials (API, Active Pharmaceutical Ingredients, excipients) testing, as well as environmental monitoring.


• Contribute in investigations and QA assessments/approval at different steps. Handles CAPA actions and follow-up on them.


• Support change control process. Contributes in action plan evaluation, approval and change control progress coordination. Ensures change controls status is in line with current activities on manufacturing site.


• Review and approves as QA representative qualification and validation activities documents (IQ, OQ, PQ, DQ, cleaning validation, process validation, QC method validation/transfer documents, …).


• Manage the planning and execution of qualification of internal stakeholders and contract manufacturers batch records for reduced review as appropriate.


• Oversee maintenance interventions on equipment to ensure cGMP compliance of production and testing processes.


• Responsible for annual QC qualification by reviewing and commenting raw data worksheets and summary result forms.


• Identify process quality and cGMP compliance related issues, interpret the situation and articulates recommendations through efficient communication.


• Contribute with his/her team to health authority’s inspections and corporate audits by supporting Quality Compliance team in the preparation of inspections and audits. Acts as SME within his/her scope of responsibilities.


• Follow up on quality metrics and makes recommendations if objectives are not met.


• Ensure the representation of QA within department and cross-functional project teams according to assignments.


• Write SOPs and makes recommendations for SOP revisions at a local and global level.


• Approve procedures and documents related to Celgene International Boudry site as part of the QA approver group.


• Responsible for directing and supervising the assigned personnel in direct line.


• Assign tasks to direct reports in accordance with their responsibilities and capabilities.


• Provide continuous support and adequate coaching to ensure direct reports fulfill their duties and objectives. Assures continuous professional development and guidance to direct reports.


• Provide a safe and healthy work environment for your staff and shall ensure compliance with relevant rules and legislation in those areas.

About Us




COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE



At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.




"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."



There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.