Director, Quality Assurance Operations
Vor 2 Tagen
**The Role**:
Reporting to the Head Quality, International Organization, the Director of Quality Assurance QA Operations will be responsible for managing and providing QA oversight and support for contract sterile manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements. This leadership role located in Basel, Switzerland will implement and manage Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international DP operations. The Director QA Operations -Drug Product will manage and provide person in plant QA presence at contract manufacturing organization (CMO) DP manufacturing sites for oversight of fill finish activities and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls. 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**:
- Lead and organize a team of up to 20 employees.
- Manage overall oversight and provide person in plant QA presence at contract manufacturing organization (CMO) Drug Product manufacturing sites to ensure adherence to approved policies, SOPs, quality agreements, batch records, regulations and to ensure timely documentation, notification/escalation and resolution of any issues and non-conformities.
- Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
- Support quality investigations and manage CAPA (corrective and preventative actions) for DP CMO activities.
- Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by DP CMOs and Contract Laboratory Organizations (CLOs).
- Provide resources to complete timely review of 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.
- Provide QA oversight at contract manufacturing DP sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna’s drug products.
- Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.
- This role requires approximately up to 40% international travel.
**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.
- Experience with sterile manufacturing activities in GMP environment.
- Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections.
- Experience in computerized systems, automation, operations and 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 to constantly learn and challenge the status quo.
**About Moderna**
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad
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