Director, Quality Assurance
vor 3 Wochen
**The Role**:
Reporting to the Head Quality, International Organization, the Director of Quality Assurance Disposition will be responsible for providing QA oversight and support of Moderna’s international organization’s product disposition for clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). This role will act as Qualified Person (QP) in accordance with EU GMP and manage other QPs to provide final certification/release along with ensuring overall maintenance of site quality management system (QMS) to support release of product for EU/EEA markets as well as wholesale distribution to EU countries. The Director of QA Disposition will ensure clinical and commercial drug substance and drug product as well as labeled and packaged product complies with cGMP, international regulatory requirements, and internal policies, procedures and specifications. This leadership role located in Basal, Switzerland will lead Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The Director Quality Assurance Disposition will collaborate with Manufacturing, QC, QA Operations, QA Systems and Compliance, Regulatory Affairs and Supply Chain to ensure Moderna’s products are dispositioned on time to meet defined turnaround times to meet supply and customer requirements and manage Qualified Persons (QPs) to support release to EU countries. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.
**Here’s What You’ll Do**:
Execute QP responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16.
Manage QPs and review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications.
Approve certificates of analysis and certificates of compliance in support of product disposition.
Manage overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines.
Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.
Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.
Facilitate and coordinate disposition of product for applicable regions and markets with Regulatory Affairs (RA), Qualified Persons (QPs) and Supply Chain (SC).
Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.
**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years.
Minimum 3-5 years’ experience acting and executing Qualified Person responsibilities and duties as defined in EU directive 2001/83/EC (as amended).
Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections.
Experience in product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry.
A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
Experience working with CMOs, CLOs, vendors, and relationship management preferred
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Track record of leading, coaching, and mentoring high-functioning and collaborative teams.
A ‘digital first’ and curious mindset that allows you t
-
Senior Quality Assurance Director
vor 1 Monat
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitGi Group SA is seeking a highly experienced Senior Quality Assurance Director to join our team in Basel, Switzerland.About the RoleThis is a unique opportunity for a seasoned quality professional to lead our Quality Assurance team and drive excellence in quality management. As Senior Quality Assurance Director, you will be responsible for ensuring the...
-
(Associate) Director, Quality Assurance
vor 1 Woche
Basel, Schweiz Ridgeline Discovery GmbH Vollzeit**Ridgeline Discov**ery is looking for an (Associate) Director, Quality Assurance**. Ridgeline Discovery, a Versant Ventures Discovery Engine, creates and operates Versant-financed innovative biotech companies in partnership with entrepreneurs, industry, and leading academics across Europe. In recent years, Ridgeline has assembled an international team of \...
-
Quality Director
vor 18 Stunden
Basel, Schweiz Thermo Fisher Scientific Vollzeit**Director, Quality Assurance**: Position summary: The Director Quality Assurance, Clinical Trial Division (CTD) is a leadership role responsible for providing leading services in Quality to ensure safe and compliant management of the Allschwil, Switzerland site. The site offers planning, manufacturing, packaging, storing, distribution and label printing...
-
Quality Director
Vor 2 Tagen
Basel, Schweiz Thermo Fisher Scientific VollzeitThe Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...
-
Associate Director Quality Assurance and Compliance
vor 2 Monaten
Basel, Schweiz Veristat VollzeitJob Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...
-
Basel, Schweiz Veristat VollzeitJob Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...
-
Director Digital Quality
vor 7 Monaten
Basel, Schweiz Panda International Vollzeit**Director Digital Quality**: **Location** - Basel, Switzerland **Business Sector** - Biotechnology **Job ref** - 22276 **Published** - about 5 hours ago **Director Digital Quality** Are you a professional with expertise in digital quality management within the Pharmaceutical and Biotechnology manufacturing industry? Join a top-tier organization in...
-
(Associate) Director, Clinical Quality Assurance
Vor 3 Tagen
Basel, Schweiz IMVT Corporation Vollzeit**Organizational Overview**: Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational...
-
Quality Assurance Director
Vor 3 Tagen
Basel, Schweiz LHH VollzeitOur client is a Medical Device Company Your next Responsibilities: - To be the Quality Management representative for the site as well as the Person Responsible for Regulatory Compliance - Establishes and maintains quality assurance programs, procedures and controls including quality control, quality engineering, product release, CAPA and non-conformances,...
-
Executive Director of Quality Assurance
Vor 7 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...
-
Associate Director, Sterility Assurance
vor 2 Wochen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Reporting to the Sr. Director of Global Quality Control, the Associate Director, Sterility Assurance, will be collaborating closely with Moderna’s network of Microbiological Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), providing guidance and direction about...
-
Associate Director, Product Quality Lead, Quality
vor 4 Monaten
Basel, Schweiz Moderna VollzeitThe Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...
-
Quality Assurance Manager
Vor 5 Tagen
Basel, Schweiz ITech Consult Vollzeit**Quality Assurance Manager (M/F/d) - cGMP / Quality requirements / analytical working / CAPA/ OOS / deviation management / English/ German** **Project**: For our customer a big pharmaceutical company in Basel we are looking Quality Assurance Manager (M/F/d). **Background**: As within Quality Assurance for Quality Control Basel/Kaiseraugst you are ensuring...
-
Quality Assurance Specialist
vor 1 Woche
Basel, Schweiz Hamlyn Williams VollzeitGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Hamlyn WilliamsValidation and Quality Assurance Consultant - Hamlyn WilliamsAre you a Quality Assurance Specialist? Do you have experience working in the pharmaceutical industry? Are you looking for a new contract?My client is a large pharmaceutical company in...
-
Quality Assurance Inspector
Vor 7 Tagen
Basel, Schweiz VHR Global Technical Recruitment VollzeitVHR is hiring for our client who provides refurbishment, aircraft management, aviation consulting and maintenance services. This is an excellent opportunity for someone looking for a permanent position with growth opportunities.Job Description:Work in accordance with applicable procedure as per the Client's AC DOE, POE, MOE, CAME and other...
-
Quality Assurance Specialist
vor 1 Woche
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob Title: Quality Assurance SpecialistWe are currently seeking an experienced Quality Assurance Specialist to join our team in Basel, Switzerland.About the Role:This is a 6-month external temporary position, where you will be responsible for ensuring that all process and product-related activities in the area of Quality Control are compliant with legal...
-
Quality Assurance Manager
Vor 3 Tagen
Basel, Schweiz Talentify VollzeitWe are currently looking for a Quality Assurance Manager that will be responsible for ensuring the quality and compliance of excipients and other direct materials, managing deviations, and collaborating with various departments to maintain inspection readiness.Tasks & Responsibilities:QA Release of excipients and other direct materials.Evaluation and...
-
Quality Assurance Manager
Vor 6 Tagen
Basel, Schweiz ITech Consult AG VollzeitQuality Assurance Manager (m/f/d) - cGMP / Quality requirements / analytical working / CAPA/ OOS / deviation management / English/ GermanProject: For our customer a big pharmaceutical company in Basel we are looking Quality Assurance Manager (m/f/d).Background:As within Quality Assurance for Quality Control Basel/Kaiseraugst you are ensuring that all process...
-
Director, External Quality
vor 18 Stunden
Basel, Schweiz Johnson & Johnson Family of Companies VollzeitJanssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, External Quality - Small Molecules - End to End Strategic Partnerships & New Modalities located in the Unites States, Puerto Rico or Europe. Preferably East Coast US location - ideally NJ or PA; Beerse, Belgium; Dublin, Ireland; Cork, Ireland;...
-
Quality Assurance Manager
vor 1 Woche
Basel, Schweiz Global Kader Personal Vollzeit**EINFÜHRUNG**: Als Preferred Supplier für Roche Basel in suchen wir eine engagierte Persönlichkeit als **Quality Assurance Manager**: (Vertragstyp 3 Monate mit Möglichkeit auf Verlängerung) mit Startdatum so rasch wie möglich oder innerhalb von zwei Monaten. Remote/Home Office: hybrid, gemäss gesetzlichen Vorgaben, on site wird...
