Associate Director, Clinical Program Management - London, United Kingdom - Moderna Therapeutics

Moderna Therapeutics
Moderna Therapeutics
Verified Company
London, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

The Role:


Reporting to the Senior Director of Pharmacovigilance Quality, Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Senior Manager 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 role will support the ongoing development and operational activities of the Local affiliate functions responsible for Moderna Clinical Safety and Pharmacovigilance (CSPV) organization, Global Regulatory Science (GRS) and Global Medical Affairs (GMA).

This includes alignment of local initiatives, goals, and activities with R&D QA goals.

Ensure local implementation of global standards and procedures.

Supports regulatory inspections and partner audits of Local affiliate within assigned region (e.g., MHRA, EMA inspections).


Here's What You'll Do:


Consults with the Moderna local affiliate functions responsible for CSPV, GRS and GMA activities to ensure the implementation of strategies regarding the processes, procedures, quality standards and vendor oversight required to maintain compliance with applicable regulations, e.g., local PSMF requirements.

Conducts audits of local affiliates, global PV Systems, vendors, and business partners as assigned.


Ensure that Moderna local affiliates within assigned region are fully prepared for regulatory inspections of GVP/ GCP-regulated activities and provide on-site support and guidance during regulatory inspections.

Provide direction and ensure inspection responses are timely and appropriate to maintain good standing with regulatory agencies.


Provide strategic input to the regional program for GVP audits (e.g., vendor, system, affiliate, & partner audits) and integrate into the global R&D Quality program, managing the audit program utilizing an innovative, risk-based approach.

Proactively identify and report systematic issues as well as opportunities for process improvements.

Oversees CAPA development, execution, closure and, as needed, escalation for CAPAs associated with stakeholder group.


Provide input into the issue management program arising from the affiliate 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.

Remain current with industry trends and draft regulations/guidance.

Participate in compliance projects and initiatives.

Contribute to the continuing development of a quality culture at Moderna.

Approximately 50% of time is spent in the audit role.

Approximately up to 30% travelling


Here's What You'll Bring to the Table:

BS/BA, MS or PhD and a minimum of 12, 10, 9 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.

10+ years' experience in pharmacovigilance operations and/or GVP QA in a global environment.

Strong knowledge of relevant FDA, EU, pharmacovigilance guidelines, and local/regional GVP regulations.

Hands-on experience of planning, leading, and reporting on global pharmacovigilance audits

Experienced in CAPA management and issue resolution

Working knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations preferred.

Experience working with CROs, vendors, and relationship management preferred.


Excellent auditing skills and ability to communicate significant observations to Principal Investigators, Senior Scientists, etc., in a sound and factual manner.

Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.

Strong leadership skills with ability to effectively organize and execute tasks.

Ability to work both independently and in a team environment.

Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.

Excellent communication and presentation skills, both verbal and written.

Ability to influence and negotiate effective solutions, excellent interpersonal skills.

Ability to manage multiple projects in a fast-paced environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.


Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

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