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AbbVie Commercial Quality Head of EEMEA (2 Year Development Opportunity) in Russia

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .

I chose AbbVie

I chose Innovation

I chose a Great Place to Work

AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people and, when we find them, we make it our business to treat them well.

We are currently sourcing a Commercial Quality Head of EEMEA to lead our high performing quality team, reporting to our Director of Commercial Quality Assurance as part of a 2-year development move . In this role, you will be responsible for providing quality assurance support for the quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics across the EEMEA region.

This is an exciting opportunity to grow your career, building and developing your leadership capabilities while developing and supporting the strategic direction of quality assurance across the global Commercial Affiliate enterprise in conjunction with the core principles of Operations QA.

Due to the international aspect of this role, you can be based in any of the EEMEA or WE countries, but you must be able to travel up to 35% within and across the regions, as required.

Has this development opportunity sparked your interest? If so, then read on to learn more about the key responsibilities….

In this role, you will be:

• Responsible for the overall strategy for integration and support of quality regulations from Operations to Affiliates and vice versa: drug, biologics, device combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance a efficiency throughout our quality systems.

• Drive effective Quality Management at the Area and affiliate level; Interact with Area and affiliate GMs and key stakeholders to support business needs commensurate to local requirements. Strive for agility with our internal and external partners for development of best practices in our quality systems and procedures applicable to affiliate operations and regulatory complexity across the global affiliate enterprise.

• Responsible for the critical interface between Operations Quality Systems Centers of Excellence (CoEs) and Affiliate QA, providing key direction and ensuring the quality systems are holistically aligned in the spirit of ICHQ9, are fit for Affiliate purposes and local regulations.

• Responsible for the management and oversight of a global team of Quality professionals including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively meet changing business and compliance needs.

• Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.

• Responsible for initiation, selection, coordination, and management of quality system projects. Lead project teams and/or direct staff in planning, prepare review and approval of quality documentation.

• Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes, and procedures. Design effective quality systems, procedures and/or processes with cross functional input to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits and internal audits.

• Lead quality system elements, training, continuous improvement, and tactical support across functions and global affiliate entities.

• Review assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within system.

Qualifications

So , what education and experience do you need?

  • A Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area.

  • 10+ years’ experience in quality assurance, quality oversight or relevant experience.

  • Proven managerial leadership of technical professionals and/or in leading cross-functional teams.

  • Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.

  • Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.

  • Knowledge of QA systems, GMP and GDP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical product and distribution thereof.

  • Experience working and/or managing in both team setting and independently. Works well with minimal manager guidance while able to manage own time teams effectively.

  • Strong oral (with all levels of management) and written communication skills needed.

  • Excellent interpersonal skills a plus.

  • Can create strategic plans integrated into the overall quality system to deliver large and complex programs or projects.

Are you ready now to lead a high performing and ambitious Quality team?

It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

Travel

Yes, 25 % of the Time

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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