Sr Associate, Quality Operations
External Posting TitleSr Associate, Quality OperationsJob DescriptionJOB OVERVIEW:
The main responsibility of the Senior Associate, Quality Operations (QO) is to serve as Project Manager for all activities needed to ensure operational readiness of the quality organization at the Solothurn site. Activities will include, but are not limited to, administration of the timeline and develop a detailed project plan associated with the quality deliverables identified by the Next Generation Quality team. Activities outlined within this timeline are required to ensure that the Quality organization is prepared to support routine operations of the new high throughput biotech production facility. The realization of these deliverables will culminate in an overarching Quality Plan specific to the operations of the new Solothurn site. This role is expected to be cross-functional between the Next Generation Manufacturing organization and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant cross functional work streams.
During the construction and start-up of the facility the Sr. Associate, Quality Operations will serve as one of the first Quality staff members at the site. The position will be responsible for close adherence to the construction and operational schedules for facility realization. The Senior Associate (QO) will support Quality management for activities related to interviewing, hiring and training of employees, as well as compliance with training policies. In addition to serving in a project management capacity for the Next Generation Quality team, this position is expected to support targeted tasks within the purview of Quality. Activities may include mapping and gap analyses of the quality management system for operational readiness, authoring procedures or policies, facilitating site management reviews and supporting regulatory inspections as the site is brought online. As such, the position is expected to have expert level knowledge of Quality System operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be given preference.
1. Administer Quality timeline and build and maintain project plan for realization of the Solothurn Next Generation Manufacturing operations.
2. Author, review and approve complex GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies.
3. Interact with Regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)
4. Supports routine site Quality operations including administration of the site master file, the Quality Plan, and Quality Management Review.
5. Identify, revise/develop and implement complex Quality systems that can be global in scopeLocationSolothurn, SwitzerlandJob CategoryQualityRequisition Number28331BRQualifications- Approximately 10 plus years of experience in pharmaceutical or biotech manufacturing environment.
- Prior experience with regulatory audits and at least 3 years of experience within Quality Assurance or related function is preferred.
- Ability to speak German is preferred.
- Prior experience with facility start-up strongly preferred.
- Must be proficient with the Quality systems and business processes associated with equipment, facility utility operations, validation and change control
- Demonstrated ability to work autonomously and to lead project teams without authority
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Strong presentation and organizational skills
- Ability to multi-task
- Demonstrated problem solving skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.EducationBachelor’s degree in Engineering or related Life Science or Technical disciplineAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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