Associate Director, Global Quality Control, Change
Vor 5 Tagen
**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, meet
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