Associate Director, Release & Compliance
External Posting TitleAssociate Director, Release & ComplianceJob DescriptionJOB OVERVIEW:
The main responsibility of the Associate Director of Batch Release and Compliance is to lead the local implementation of Biogen global quality systems at the Solothurn Site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations. This function has the overall responsibility to ensure the requirements of the Quality System Regulations is effectively established and maintained and is also intended to take on the Responsible Person role for the Solothurn Site.
The new facility and the production process in Solothurn will rely on highly integrated business execution systems, such as Delta V (production automation), Syncade (batch records), Infor10 (enterprise asset management, i.e. maintenance and calibration), KNEAT (validation documentation), Labware LIMS (test data) and Oracle (ERP). It is therefore pivotal for the Associate Director of batch disposition and Compliance to have profound experience with quality systems within a manufacturing paradigm based on recipe-based operations in a highly automated, paperless biologics manufacturing environment. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements. The intended control strategy will include PAT, hence experience with this concept as well as risk management (risk register and risk assessments) will be considered an advantage.
The holder of this position will be responsible for ensuring that the site is GMP ready as per project schedule. This will include, but is not limited to: batch release (responsible person), maintaining Site Master File, Quality point of contact for technology transfer, responsible for site management review, host of audits and inspections, point of contact for corporate quality functions (internal and external auditing, regulatory intelligence, documentation control, training, exception and CAPA management.
1. Designs and Manages the Solothurn Release and Compliance Team of subject matter experts who themselves are responsible for specific functions according to job descriptions.
2. Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn.
3. Design, review and maintain quality plan for the Solothurn site to ensure site GMP readiness as per project timeline.
4. Represent Solothurn Quality within the global quality organization to ensure local implementation of the global QMS
5. Once operational, serve as the Quality lead and Responsible Person for batch release & compliance.
6. Ensure site training plan and system for content/documentation are in place and maintained..
*LI-POT4LocationSolothurn, SwitzerlandJob CategoryQualityRequisition Number28331BRQualifications- Approximately 10 plus years of experience in pharmaceutical or biotech manufacturing environment.
- Prior experience with fully electronic operations and management is preferred.
- This position will require frequent international travel during the first two years of employment (up to 30% at times), periodically thereafter.
- Dual Language preferred with a preferences for German and English.
- Prior experience with facility construction and start-up strongly preferred.
- Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- 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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