Associate Director, Qa For Qc Method Trending And Validation

The Role:
Moderna is seeking a seeking a highly motivated Associate Director Quality Assurance responsible for ensuring the accuracy, transfer, and trending of the methods used in the development, testing, and release of mRNA therapeutics and vaccines. The primary focus of this role is to oversee the validation of analytical methods and to ensure compliance with regulatory requirements and to oversee improvements in the programs with the use of artificial intelligence or machine learning algorithms. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This role will support the Quality Control laboratories in Norwood, MA and Madrid Spain in addition to QC testing performed in the network of Moderna’s CMOs.
Here’s What You’ll Do :
Oversee, support, and improve a comprehensive method validation program that includes protocols, reports, and standard operating procedures (SOPs) for new and existing analytical methods.
Collaborate in the development of a global analytical trending program to ensure the performance of methods across Moderna’s Quality Control laboratories and those of it’s CMOs.
Ensure that all analytical methods are validated according to regulatory requirements and industry standards.
Review and approve method validation protocols, reports, and other documentation related to analytical method validation.
Ensure that all analytical instruments are calibrated and maintained according to SOPs and regulatory requirements.
Provide guidance and support to analytical development teams to ensure that analytical methods are developed and validated in a timely and efficient manner.
Collaborate with cross-functional teams to ensure that analytical methods are transferred and implemented effectively.
Participate in regulatory inspections and audits and ensure that all analytical methods and related documentation are compliant with regulatory requirements.
Identify and implement continuous improvement initiatives to enhance the efficiency and effectiveness of the method validation, transfer, and trending program using AI and machine learning techniques
Mentor a team of quality assurance professionals to ensure that all activities are completed according to established timelines and quality standards.
standards.
Review relevant sections of regulatory filings
Provide guidance on analytical testing in Quality Control from Phase I to Commercial
Here’s What You’ll Bring to the Table:
BS or equivalent Chemistry, Biochemistry, or related field and 10 - 15 years of experience, or a master’s level degree and 8 - 10 years’ experience in the pharmaceutical biotech industry
Strong knowledge of regulatory requirements related to analytical method validation, including FDA, EMA, and ICH guidelines.
Experience with a wide range of analytical techniques, including HPLC, qPCR, GC, dissolution, and other compendial methods.
Experience with AI technologies, including machine learning, statistical analysis, and data visualization
Strong leadership and management skills, including the ability to manage a team of professionals and prioritize tasks effectively.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Strong problem-solving and analytical skills, with the ability to identify issues and implement effective solutions
Some travel may be required (~20%).
The position may require working outside of normal business hours to meet project deadlines or participate in regulatory inspections or audits.
Current Benefits and About Moderna sections added at time of job posting.
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:

• D iscretionary year-end shutdown
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• 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!
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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)
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