Job description
The Role:Moderna is seeking an Associate Director for regulatory compliance to serve as a lead for establishing and maintaining the Laboratory compliance, and being the ground link with Quality Assurance, the scientific team and the Operation Lead. The Associate Director for Laboratory Compliance will serve as a centralized point of contact to ensure the compliance of the entire governance of the clinical Laboratories network.
The candidate will play a critical role in the resilience of the Clinical Biomarker Lab at Moderna to ensure operational continuity. The role will be responsible for leading and maintaining compliance efforts to meet regulatory checkpoints across multiple laboratory and functional areas including governance document management, SOPs writing, version control and Operations. The candidate will provide guidance to the clinical biomarker Leads with an emphasis on end-to-end laboratory operations. The Associate Director for Laboratory Compliance will develop strong and efficient business relationship with the Leadership team in UK, with the objective to grow his team toward global reach for ensuring compliance of operational activities.
The Associate Director for Laboratory Compliance will ensure of the development of the Biomarker Laboratory team members skills, ensure that staff training is in order and new training listed across the teams. The candidate will establish metrics across its responsibilities to monitor compliance and will present results to the Biomarker Laboratory leadership . The position reports to the Senior Scientific Director, Clinical Biomarker Laboratory.
Here’s What You’ll Do:
Issue management.
Leading non-conformance investigations in the context of existing documents and processes at Moderna
Recognize, address and accurately capture issues and documentations with owners
Ensures a consistent approach, reassuring to regulators
Ensures scientific staff are free to deliver testing.
(Common non-conformance examples in laboratories include temperature excursions, pipette calibration failures, SOP’s not being followed, documentation errors. With equipment failures/excursions impact to study samples, testing, data needs assessed)
Facilitate root cause analysis with scientific team, determination of Corrective and Preventative actions. Ensuring CAPA are documented corrected and actioned timely manner by scientific team.
Owns the local internal audit SOP. Perform regular process, study, and facility audits in preparation for QA and regulator audits. Own /issues the audit schedule. Write audit reports working with team to resolve issues.
Train team on local compliance, fostering a culture quality and data integrity. Keeps team updated on emerging quality recommendations and guidelines.
Perform recurrent team Training record checks.
KPI dashboard for laboratory quality compliance, issues, audit actions, training. Present to leadership team.
Lead and performs SOP’s version control with Quality assurance or more frequent to include CAPA actions, process improvement. Compliance lead coordinate the review of SOP’s with SME to ensure all actions completed. Assist in the drafting of new SOP’s.
Facilitate the change control processes for the laboratory (i.e. new equipment into established lab, critical updates to validated Method and SOP’s, updated to specifications)
Review analytical study plans and reports for compliance to SOP’s.
Assist scientific team to ensure laboratory and study documentation is retained correctly and prepared for archiving and in line with ALCOA+ principles.
Lead a global team of direct staff reports to reach across the Clinical Biomarker Laboratory network in Norwood, USA and in Harwell, Oxfordshire, UK
Here’s What You’ll Bring to the Table:
Minimum of 5 to 8 years of relevant experience required in regulated/ Compliant laboratory environment
Masters/ Bachelor within drug development at pharmaceutical, biotech or CRO
Previous experience in working in CAP/ CLIA, GLP, GCP regulated laboratory is required
Minimum 5 years of resource management experience
Knowledge in clinical sciences and technology is required
Previous experience leading, reviewing, managing governance documents, access and archiving to vault highly preferred
Attention to detail, organizational ability, clinical judgement, and good communication skills
High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail
Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
Some travel may be required to visit the CBL facility in the United Kingdom
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
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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