Associate Director /Director, Quality Systems and Compliance
Reporting to the Sr. Director Quality Assurance, GMP Quality Site Head, the AD/D of Quality Systems and Compliance will be responsible for building world class quality system processes and operations to ensure Moderna exceeds the highest level of compliance while monitoring the health of the Quality Management System (QMS) for continuous improvement as we continue to move more of our therapies into the clinic. This leadership role at Moderna's state of the art 200K square foot cGMP Norwood manufacturing facility will continue to build a culture of quality at the site and provide strong leadership and strategic direction of Moderna's QMS consisting of Quality Assurance, Validation, and Compliance and ensure overall quality of our investigational drug processes and drug candidates at Norwood. 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:
- Continue to improve Moderna's overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.
- Provide cross functional quality leadership and act as a subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, cGMP compliance, and in business matters involving facility and laboratory operations.
- Work collaboratively with the digital team on the GXP integrated digital landscape to support all e-systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.
- Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
- Manage validation master plans and oversee all commissioning, qualification, and validation activities, including computer system validation, for quality control laboratories, manufacturing and overall operations to deliver on early to late phase clinical programs at the Norwood cGMP manufacturing facility which includes raw material, plasmid, drug substance, formulation, drug product, finished goods and personalized medicine capabilities.
- Oversee the performance of Moderna's QMS by leading Management review meetings and monitor the state of control and overall quality of Moderna's drug substances and drug products.
- Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.
- Manage the internal audit program and third party/regulatory inspection programs for the Norwood cGMP manufacturing facility.
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; 8-10 with MS.
- Working knowledge of relevant FDA, EU regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
- Experience in computerized systems, automation, operations and manufacturing within biotechnology industry and in a new manufacturing facility startup environment is a plus.
- 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, cross-functional matrix environment.
- You drive for results and set a high bar for yourself and others. You love what you do, and it shows.
- A ‘digital first' and curious mindset that allows you to constantly learn and challenge the status quo.
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.