Sr. Specialist, Quality Assurance Auditor
Moderna is seeking a Senior Quality Assurance Auditor for a position based at their Norwood, MA facility. The individual in this role will be responsible for providing Quality Assurance (QA) support for Moderna's Supplier Quality program. The individual will primarily work with Supply Chain and vendors to ensure a robust supply of GMP materials are available to support Moderna's clinical manufacturing programs. This individual will support supplier quality systems and governance, initiate audit plans, audit vendors, and drive continuous GMP improvement in the supply chain. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. Additionally, the individual we create and maintain data tracking systems that govern the supplier quality program. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.
Reporting to the Associate Director of Quality Assurance, this person will be responsible for auditing Moderna's suppliers and will be accountable for monitoring supplier performance.
Here's What You'll Do:
- Execute supplier audits
- Partner with supplier to establish relationships
- Aide in the establishment and maintenance of policies and procedures for the supplier management program
- Develop Audit Plans
- Monitor supplier metrics to ensure supplier performance is measurable
- Maintain supplier data
- Track supplier conformance to audit commitments and corrective actions (SCAR's)
- Review supplier change notifications and determine impact to internal systems
- 30% Travel
Here's What You'll Bring to the Table:
- BS in a scientific or engineering discipline
- 5 + years' experience in pharmaceutical / biotech industry within Quality Assurance executing audits; MS preferred with 2-5 years' experience
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
- Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures. Requires thorough knowledge of the department and company operations, policies and procedures.
- High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.
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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
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.