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MSD Director Quality Assurance Value Chain Management - Global Hybrid Ireland 438956619
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Job Description
in Quality Assuto support the end-to-end program for our assigned Product Value Chain inAntibody Drug Conjugates).You will bekey member and sit onthe Value Chain, ensuring compliance and driving manufacturing excellence throughout the commercial lifecycle of the product. Collaboration, coaching, and facilitation are at the core of our team's working style, ensuring program success through quality support, oversight, and.
Key Responsibilities:
Support the product program from a quality perspective, ensuring compliance with current procedures.
Collaborate with the Quality, Regulatory, Technical, and Supply Chain pillars.
Develop the Product Quality Strategy, aligning it with the product supply strategy and documenting it effectively.
Create the Product Analytical Strategy, including elements such as testing laboratories, testing duality, and stability.
participateand lead product focus teams, providing qualityexpertise, support, and advice.
Improve Quality Systems and operational quality by solving complex problems and driving continuous improvement.
Implement and oversee applicable Quality Management Systems and standard ways of working to ensure a supply of quality products.
Stay up to date with regulatory/compliance requirements and apply them effectively.
Liaise with Corporate Quality to ensure alignment on Quality Systems and operational quality actions.
Participate in inspections asrequiredand champion Permanent Inspection Readiness (PIR) for the product program.
Collaborate with other sites to share best practices and ensure alignment on Quality System-related topics.
Act as a qualitydesigneefor Global Product Quality as needed.
Drive communications across the Quality Network by leading meetings, activelyparticipating, and escalating relevant issues/risks to Quality sponsors.
with the development of the Analytical Siting Strategy.
Track change control metrics and complaint metrics for the franchise.
Evaluate the franchise's Annual Product Review for supply chain trends and escalaterisksas necessary.
Review and approve Sister Site Evaluation and Post Marketing Product Review.
Monitor and mitigate franchise Quality risks.
Partner with site Quality representatives to track Quality performance data.
Lead orparticipatein VCMTchartered projects and track their progress.
Act as the Quality Representative to VCMTand associated working groups.
withtheQualityleadsto resolve supply chain quality issues.
Requirements:
At least ten years of experience in thePharmaceuticalindustry,withleadershipexperience.
Quality experience and/or technology experience in Vaccines or Large Molecule Operating Unit is preferred.
Continuous Improvement(CI)experience or Analytical experience is desirable, but notrequired.
Strong project management skills and excellent communication skills.
Experience leading multi-functional teams to execute strategic actions.
Degree or post-graduate qualification in Science, Pharmacy, or Engineering field.
Demonstrated ability to drive change and improvement initiatives.
Strong leadership behaviors and stakeholder management skills.
Continuous Professional Development and a focus on continuous improvement.
Successes in team environments, such as project teams, Six Sigma teams, or CI teams.
Good communicationand interpersonal skills.
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 Contingent Workers apply
Secondary Language(s) Job Description
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Pleasehesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about
So, if you are ready to:
Invent solutions to meet unmet healthcare needs,
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Pleaseif you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. 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 aagreement (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 “remote”.
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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