Senior Manager, Quality Assurance

🕒 il y a 1 mois

🇨🇭 Suisse – Télétravail

⏰ Temps Plein

🟠 Senior

🔧 Ingénieur QA

👻 Score fantôme 11%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Acadia Pharmaceuticals Inc.

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 1993

🏥 Santé

💊 Pharmaceutique

🧬 Biotechnologie

💰 €287 500 000 Post-IPO Equity en 2019-09

Healthcare • Pharmaceuticals • Biotechnology

Acadia Pharmaceuticals Inc. est une entreprise pharmaceutique spécialisée dans les avancées en neurosciences pour améliorer la vie. Depuis plus de 30 ans, Acadia est à la pointe des soins de santé, développant des traitements pour des affections telles que la psychose de la maladie de Parkinson et le syndrome de Rett. L'entreprise est axée sur le développement de médicaments innovants et novateurs qui répondent à des besoins médicaux non satisfaits, notamment dans des domaines thérapeutiques à forte demande, comme le syndrome de Prader-Willi, la psychose de la maladie d'Alzheimer et d'autres troubles du système nerveux central. Acadia est dédiée à l'amélioration de la vie en embrassant des perspectives diverses, favorisant la collaboration et faisant progresser la recherche et le développement scientifiques.

Description

• Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation. • Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates • Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations • Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations • Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement • Participates in GMP supplier audits and Acadia documentation control systems as needed • Manages and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations • Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations • Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation and change management activities. • Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards • Ensures adequate QA representation on all GMP product development teams; provides direction to QA representatives on these teams • Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect • Participates in Quality Operations functions such as: Material Review Board, quality board, strategic planning efforts, etc., as may be required • Participates in formal risk assessment activities as required • Develops and/or contributes metrics to support product and/or process review efforts as needed • Develops department goals and objectives for senior management review in alignment with Acadia strategic planning • Other duties as assigned/required

🎯 Exigences

• Pharm D, Master´s or Bachelor’s degree in Chemistry/Biology/Pharmacy or related life science is required. A minimum of 5 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry. • Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and Swissmedic/EMA/MHRA and other international GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer • Demonstrated proficiency in interpretations of cGMP regulations for Swissmedic/EMA/MHRA and other international regulations. • Experience implementing and managing quality management systems is an advantage • Experience conducting internal and supplier audits and manufacturing facility inspections is an advantage • Ability to interpret and relate Quality standards for implementation and review • Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize • Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. • Able to gain cooperation of others • Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals • Able to make and prioritize process and resource decisions based on overall team needs • Experience in a global organization; ideally in the EU or Switzerland • Fluent in spoken and written English (additional European language(s) an advantage) • Travel 25-40% may be required (including international)

🏖️ Avantages

• Competitive base, bonus, new hire and ongoing equity packages • Medical, dental, and vision insurance • Employer-paid life, disability, business travel and EAP coverage • 401(k) Plan with a fully vested company match 1:1 up to 5% • Employee Stock Purchase Plan with a 2-year purchase price lock-in • 15+ vacation days • 13 -15 paid holidays, including office closure between December 24th and January 1st • 10 days of paid sick time • Paid parental leave benefit • Tuition assistance