The Director/Sr. Director, Quality Operations will be part of a cohesive team responsible for supporting cGMP manufacturing of mRNA-based medicines. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects and aligns with global regulatory expectations. The successful candidate will have experience in quality oversight in clinical and commercial products. Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and management in Manufacturing and cross functionally with Quality Control, Logistical and Process Development Technology Transfer counterparts.
This role will support the growing Personalized Cancer Therapy Program at the Norwood, MA site.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Develop, build, and lead quality operations teams for a clinical manufacturing execution team in Norwood, Ma site.
- Provide leadership, guidance, and coaching for all direct reports to maintain an engaged and productive workforce
- Ensure the quality policy and objectives are understood, implemented, and maintained at all levels of the organization.
- Develop short and long-term plans to achieve both quality and business objectives.
- Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy and meet all relevant regulatory requirements including federal, state and international regulations and applicable standards and guidance's.
- Provide guidance, support and oversees all activities related to batch record review and product disposition for clinical manufacturing at Moderna Inc.
- Provide guidance, support and oversees all activities related to QA functional areas: Quality Systems, Deviations Management, Technology Transfers, Change Management, Quality Control and GMP Facilities.
- Provide guidance, support and oversees all activities related to on the floor support for manufacturing such as reviewing documents and providing real time support of manufacturing issues.
- Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement.
- Responsible to assure that there are no significant interruptions to the business due to quality or compliance issues.
- Design, build, and continuously develop top tier quality assurance operations teams in connection with company's strategic goals, quality objectives and to scale with Moderna operations.
- Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations.
- Interface directly with Partner programs and if needed, regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Bachelor degree, preferably in Sciences or Engineering with applied Quality industry Experience of 10-15 years; 8-10 with MS.
- Experience within ATMP's a plus
- Working knowledge of relevant FDA, EU regulations especially with respect to ATMP's ICH standards/guidelines and experience in hosting and facilitating successful regulatory inspections and Partner audits.
- Experience in computerized systems, automation, operations and manufacturing within biotechnology industry and in a new manufacturing facility startup environment is a plus.
- Sound understanding of phase appropriate GMPs, with previous experience in early to late phase parenteral drug substance and drug product.
- 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).
- Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
- Ability to be agile and effectively collaborate in a dynamic, fast paced cross-functional matrix environment
- Self-driven and results orientated.
- A 'digital first' and curious mindset that allows you to constantly learn and challenge the status quo.
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary winter shut down
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
In over 10 years since its inception, Moderna has transformed from a 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 seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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