Sr. Director, Pharmacovigilance Quality

Company: Moderna Therapeutics
Location: Cambridge
Posted on: February 25, 2021

Job Description:

The Role:
Reporting to the Vice President of Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Sr. Director of Pharmacovigilance Quality (PVQ), will be a key contributor in growing and shaping Moderna's newly-established R&D Quality function focusing on contributing to building a highly functioning team of R&D quality professionals. This leadership role will provide oversight, strategic direction, management support and guidance for building and maintaining a function within the RDQ organization that is responsible for quality oversight and support of (i) the Moderna pharmacovigilance system, (ii) pharmacovigilance activities conducted by Moderna and its service providers, (iii) providing compliance support to the Moderna PV organization, (iv) establishing and maintaining a robust global audit program for PV, and (v) managing Regulatory Authority inspections of Moderna's PV system. Additionally, the Sr. Director, PVQ will aid in the establishment of Annual Audit Plans. The appointee will also be responsible to partner with PV organization to create a quality culture within Moderna and drive toward a sustained state of inspection readiness. Here's What You'll Do:

• Participate in the development of quality and compliance strategies for the support of global pharmacovigilance activities.
• Work closely with the Moderna Global Pharmacovigilance and R&D Quality QMS to support development of R&D policies and procedures related to PV activities.
• Partner closely with members of Global Pharmacovigilance and the QPPV to support the successful and compliant execution of Moderna PV activities.
• Develop and maintain Annual Audit Plans for the R&D Quality GVP audit program.
• Review and provide input into the quality sections of the PSMF.
• Ensure any critical and major audit findings are entered into the PSMF and tracked to completion and verification of effectiveness.
• Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.
• Actively participate as a key member of the inspection team for inspections of Moderna's pharmacovigilance system.
• Provide expert guidance and direction in the development of responses to Regulatory Authority inspection findings for inspections of Moderna's PV system.
• Participate in regulatory authority inspections, including serving as Inspection Host, as necessary, and provide input and review of responses to inspection observations and regulatory agency questions resulting from these inspections.
• Contribute in the continuing development of a quality culture at Moderna.Here's What You'll Bring to the Table:
  • BS/BA, MS or PhD and a minimum of 20, 15, 10 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.
  • Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable GVP regulations, guidelines and local legislation.
  • Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
  • Experience working with CROs, vendors, and relationship management.
  • Strong interpersonal skills and ability to interact effectively with all levels within the organization.
  • Proven record training, mentoring, and managing a staff of quality professionals.
  • Experience leading / hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.
  • Ability to solve complex problems taking a broad perspective to identify innovative solutions.
  • Ability to manage multiple projects in a fast-paced environment.--
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Here's What We'll Bring to the Table:
    • On-site subsidized cafeteria or catered lunches
    • Company-provided iPhone
    • Free parking, monthly subway pass or a subsidized commuter rail pass
    • Free annual corporate membership to Bluebikes
    • 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
    • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
    • 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 (includes 2 floating holidays) About Moderna: In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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. #LI-AG1- Posted 11 Days Ago Full time R3677 About Us 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 M oderna 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.

Keywords: Moderna Therapeutics, Cambridge , Sr. Director, Pharmacovigilance Quality, Executive , Cambridge, Massachusetts