EQA VACCINES PLATFORM LEAD

Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
We are currently seeking an External Quality Assurance (EQA) Vaccines Platform Lead to provide Quality oversight for manufacturing, testing, storage, and distribution of vaccine products at external entity sites in the Asia Pacific (AP), Middle East Africa (MEA), and South American regions.
Main Responsibilities.
Establish and maintain effective relationships with external partners to ensure reliable supply of company products in accordance with all applicable regulatory requirements, filings, policies, and procedures.
Conduct due diligence audits and technical assessments to inform external entity selection decisions.
Provide subject matter expertise in sterile manufacturing best practices, quality management systems, vaccine technologies, and regulatory requirements.
Work independently and lead complex, cross-functional initiatives to optimize Quality and business processes at both company and external sites.
May also serve as a representative of the company in external forums.
Manage all aspects of end-to-end external entity performance and serve as the primary contact for the relationship.
Establish clear expectations, measures, and periodic monitoring of operational and quality performance for each external entity in the platform.
Lead quality due diligence assessments for pre-approval consideration of new external entities (contract manufacturing or alliance partners) Lead significant manufacturing and laboratory investigations, inclusive of fact findings and regulatory notifications as required.
Establish and maintain Quality Agreements and contracts.
Effectively engage, both in person and virtually, with a global, multi-cultural team Serve as member of the EQA Vaccines Leadership Team, supporting shared business objectives across all global platforms.
Contribute to development and adherence to annual budget and efficiencies.
Demonstrate company Leadership Behaviors in all interactions with company and external personnel.
Collaborate with other functional teams to continuously improve quality and business outcomes.
Expected travel ~25% Minimum Education Requirement and Experience.
Bachelor's degree (BS) in a Science, Engineering, or related areas of study with ten (10) years' relevant experience in the pharmaceutical industry and\/or biotechnology; specifically having sterile manufacturing experience, including drug product and\/or drug substance.
Required Experience and Skills.
Vaccines experience is strongly preferred.
Communicates in English, both verbally and in writing Must have strong interpersonal, communication, coaching, and negotiation skills to build strong relationships.
Prior people \/ team management experience preferred.
This role can be based in any of our locations in the US or EU NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only.
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Hybrid Work Model Effective September , employees in office-based positions in the U.
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will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as \