Novartis has flagged the Global Commercial Execution Sales Force Automation Director job as unavailable. Let’s keep looking.

Associate Director, Global Quality Control, Change Controls & Deviations

Moderna Therapeutics

The Role:

Reporting to the Sr. Director of Global Quality Control Standards and Policies, the Associate Director, Global QC Change Controls (& Deviations), will be collaborating closely with Moderna’s 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.
  • Leading 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. 

Here’s What You’ll Do:

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

  • act as Global Owner, coordinating a team of Global QC Managers Change Controls (& Deviation) for any QC relevant Change Control globally relevant.
  • Define implementation strategy in alignment with Life Cycle and Strategy Boards for any QC relevant Change Control globally relevant.
  • Execute implementation strategy supported by the team of Managers under his/her coordination.
  • Execute personally, as required, implementation strategy (acting as Action Owner/SME).
  • Align always within the extended QC community (including Moderna AD, ATO, AS&T & QC Labs, Moderna External QC organization and QC Labs from affiliated CMOs/CTOs).
  • Represent, in person or by delegation to team members, 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.
  • Coordinate (or lead if required) investigation activities in the area of global QC business processes.
  • collaborate with Moderna extended QC community, interacting with QC Norwood, with Moderna External 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 External 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 Moderna’s 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.

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

  • Bachelor’s degree with a minimum of 15 years of experience in the pharmaceutical industries, with 5+ years’ experience coordinating QC relevant Change Controls in international 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 Change Control/Deviation 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 (highly proficient in project management).

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!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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) 

#LI-AK2


Read Full Description
Confirmed 10 hours ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles