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ModernaTX, Inc.
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Manager, Quality Assurance
ModernaTX, Inc. Norwood, MA
$111k-140k (estimate)
Full Time 4 Months Ago
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ModernaTX, Inc. is Hiring a Manager, Quality Assurance Near Norwood, MA

Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home The Role Moderna is seeking a Quality Assurance Manager to lead a team of QA Associates responsible for quality oversight of Quality Control at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA. This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of Quality Control, with a focus of providing on-the-floor support for QC. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, Facility and other teams. Here’s What You’ll Do Manage a team of QA Associates responsible for providing on-the-floor quality oversight of Quality Control (Micro, Chem, Bioassay, Stability, Sample Management and Raw Material) Identify risks and communicate gaps for quality and GMP process/systems. Coordinate training, professional development, and growth of the Quality Assurance QC Team. Additionally, advise and coach team on day-to-day tasks/projects. Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Reviews and approves facility alarms, facility work order requests, and return-to-service documentation. Reviews and approves Deviations, Laboratory Events and OOS Laboratory Investigations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/correction actions. Ability to manage multiple projects in a fast-paced environment. Collaborate and lead effectively in a dynamic, cross-functional matrix environment. Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations. Practice safe work habits and adhere to Moderna’s safety procedures and guidelines. Utilize knowledge to improve operational efficiency. Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems. Other activities as deemed necessary. Here’s What You’ll Need (Minimum Qualifications) 5-10 years of experience in a GMP manufacturing environment within Quality (Quality Assurance and Quality Control), with a bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related field. 2-3 years of Management experience Here’s What You’ll Bring to the Table (Preferred Qualifications) Proven track record of success in a fast-paced production environment at a GMP biotech/pharmaceutical company. Working knowledge of relevant FDA, EU, ICH guidelines and regulations. Outstanding communication skills (verbal and written). A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: 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. -

Job Summary

JOB TYPE

Full Time

SALARY

$111k-140k (estimate)

POST DATE

11/24/2022

EXPIRATION DATE

03/25/2023

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The job skills required for Manager, Quality Assurance include Quality Assurance, Quality Control, Planning, SOP, Coordination, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, Quality Assurance. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manager, Quality Assurance. Select any job title you are interested in and start to search job requirements.

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If you are interested in becoming a Manager Quality Assurance, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Manager Quality Assurance for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Manager Quality Assurance job description and responsibilities

Quality Assurance Managers are also responsible for managing staff, overseeing production processes, analyzing data, and developing strategies or policies for higher quality.

04/16/2022: Spartanburg, SC

Ensures that only acceptable, functional, and quality products are distributed to businesses and consumers.

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Quality assurance managers help develop and maintain quality standards.

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Quality assurance managers help companies establish quality regulations for products and employees.

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They plan, direct or coordinate quality assurance programs and formulate quality control policies.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Manager Quality Assurance jobs

When a product lacks quality, the customers are not happy and the business can suffer.

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Develop and Maintain Evaluation Forms.

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Get Experience Required for Certified Quality Engineer Certification.

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Trained employees will be prepared to face problems and, therefore, can resolve them as soon as they occur and sometimes even before the customer can perceive the error.

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Acquire quality assurance knowledge of tools and methodologies.

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