Sr. Manager, Quality Assurance Operations Drug Substance - Team Lead - Basel

Jobinhalt

The Role

Reporting to the AD of Quality Assurance Operations for the International Organization, the Senior Manager QA Operations will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.

The Senior Manager QA Operations will support Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The incumbent will act as a team leader for the QA Operations staff who is responsible for drug substance activities. The incumbent will provide person in plant QA presence at contract manufacturing organization (CMO) sites for oversight of drug substance 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

• Provide person in plant QA presence at contract manufacturing organization (CMO) sites to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.

• 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 CMO activities.
• Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs and Contract Laboratory Organizations (CLOs).
• 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.
• Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna’s drug substance.
• Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues.
• Supervise QA Operations team who are responsible for drug substance activities.
• This role requires approximately 40% international travel.
  

Here’s What You’ll Bring To The Table

• Minimum education requirement is a Bachelor’s degree, preferably in Sciences or Engineering

• Industry Experience of 8+ Years
• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
• Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry.
• Fluency (written / spoken) in English – fluency in other languages is advantageous
• 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.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• 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 promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.