Manager, Global QC Change Controls and Deviations

The Role:

Reporting to the Sr. Director of Global Quality Control, the Manager, Global QC Change Controls (& Deviations), will be collaborating closely with Modernas network of QC Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), with the main following responsibilities (not exhaustive):

• Governance of QC relevant Change Controls globally relevant.

• Supporting Global QC function in terms of Laboratory strategy and operational standards, continuous improvement initiatives and projects.

This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.

The individual will also act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, MS&T, Regulatory and Technical Development.

Heres What Youll Do:

Within the scope of Quality Control Change Controls, globally relevant:

• act as Change Owner/Coordinator for any QC relevant Change Control globally relevant.

• execute implementation actions (Action Owner/SME) of all (local, regional) QC relevant Change Controls globally relevant.

• align always within the extended QC community (including Moderna AD, ATO & QC Labs, Moderna International QC organization and QC Labs from affiliated CMOs/CTOs).

• represent Global QC in any Change Control board (local and global);

• for Change Controls not owned by Global QC, act as SPoC (Single Point of Contact) versus other groups/functions (Supply Chain, Regulatory, Quality, MS&T, AS&T).

Within the scope of deviation coordination activities for Global QC function:

• manage, end to end, deviation process flow in case of QC relevant global deviations.

• lead investigation activities in the area of global QC business processes.

• collaborate with Moderna extended QC community, interacting with QC Norwood, with Moderna International QC organization and, if required, with CMO/CTO QC Labs, in the context of Laboratory deviations and OOS/OOE/OOT events.

Within the general scope of the role, within Global QC function:

• be an active member of Moderna extended QC community, interacting with QC Norwood, with Moderna International QC organization and, if required, with CMO/CTO QC Labs.

• provide technical support, in the context of QC testing, for sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections).

• support Annual Product Quality Review (APQR) activities.

• work closely with QC Labs, Digital/IT and AD/ATO to implement automation and introduce novel approaches/technologies to improve overall analytical method performance and throughput (designing QC testing technology capability roadmap).

• harmonize/optimize of multi-site common QC processes in Modernas testing facilities and in affiliated contract organization (Manufacturing/Testing) facilities.

• collaborate for proactive identification of risk and compliance issues, manage prioritization of transformational and continuous improvement activities to deliver efficient laboratory solutions.

Heres What Youll Bring to the Table:

• Bachelors degree with a minimum of 5-7 years of experience in the pharmaceutical industries, with 3+ years experience coordinating QC relevant Change Controls in a cGMP organization. Advanced degree preferred, fluent in written and spoken English.

• Deep understanding and experience with EU, US and ICH guidelines and regulations.

• Good experience in managing product specifications globally relevant, both in commercial and development phases.

• Good experience in coordination of Globally relevant Change Controls, affecting QC operations.

• Good experience in assessing, writing, and evaluating deviations, laboratory deviations and Laboratory OOSs/OOEs/OOTs.

• General experience in data analysis and statistical evaluation and trending of data.

• Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Experience participating in inspections as a Stability/QC testing (SME) and in direct interactions with world-wide/diverse Health Authorities (e.g. FDA, MHRA, EMA, PMDA, ANVISA).

• Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.

• Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).

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 year-end shutdown
  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 persons 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.

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