AbbVie

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose Statement (2-3 Sentences):

Describe the primary goals, objectives or functions or outputs of this position:

This position is central to advancing the strategic vision and enforcing robust oversight of Quality Compliance in

affiliate, serving as the critical link between regulatory excellence and operational integrity.

The role will be advocating for comprehensive support across all affiliate quality activities related to pharmaceutical

products, medical devices, combination products, and biologics. With critical support on risk management, agency

inspections, internal audits, CAPA, and holistic Quality oversight, this role ensures the organization’s alignment with

the highest quality and compliance standards. She/he will provide strategic support for clinical operations,

rigorously supervising quality control processes to ensure compliance with industry standards and regulatory

requirement. This role will lead collaboration with cross-functional teams, driving continuous improvement

initiatives, support quality activities on development roadmap for both pharmaceutical products and medical

devices. By embodying a catalyst for excellence, she/he not only fosters transformative change but also instills a

culture of unwavering quality and compliance throughout the organization, elevating its reputation and efficacy in

the global arena.

Major Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Develop Affiliate Quality Strategy: Develop and offer affiliate quality execution strategy directions to

clinical operations teams to optimize quality and process for clinical trial execution, ensuring effective

management between quality and study timeline.

• Enhance Affiliate Quality Process: Collaborate with internal cross-functional stakeholders to develop and

optimize Quality related processes, ensuring compliance and enabling smooth integration within local and

global requirements.

• Collaborate on Quality Strategic Management & Planning: Work with CDO leadership and relevant

departments to formulate comprehensive strategic and operational plans for clinical trials, guiding affiliate

CDO team in developing and executing specific quality oversight and execution plans.

• Oversee Clinical Trial Quality in China: Regularly review study related risk and quality, guiding operational

team in identifying issues and issuing risk warnings to ensure timely advancement.

• Develop and Guide Risk identification & Mitigation Plans: Create risk identification and mitigation

strategies and instruct team in their execution to ensure health and continuity of clinical trials.

• Ensure Regulatory Compliance: Proactively track regulatory requirements and updates, coordinating

cross-departmental resources to align HGR applications with global standards, thereby enhancing the

efficiency of study start-up processes.

• Quality Knowledge Development: Conduct quality related training and knowledge-sharing to enhance team

expertise and optimize performance.

• Facilitate Cross-Functional Communication: Organize cross-departmental meetings to foster

communication and collaboration among team members, promoting the establishment and implementation

of standardized processes.

• External intelligence: Develop and build relationships with industry quality platform and gain industry good

practice and taking back to AbbVie. Leverage industry experience to develop internal quality strategies to

support internal business enhancement.

Qualifications

• Qualifications:
• List required and preferred qualifications (up to 10). Include education, skills and experience.
• Bachelor's Degree or Higher: A bachelor's degree in life sciences, medicine, pharmacy, biochemistry, or
• related fields is required. Advanced degrees, such as a master's or Ph.D. in clinical research, public health,
• or health administration, are preferred.
• Quality Experience: at least 1 years’ experience in clinical quality management, with good Quality
• Management System and GxP compliance concept.
• Project Management Experience: Strong project management skills. At least 2 years’ experiences in clinical
• trial management. Experience in clinical trials at global pharmaceutical company is required.
• Clinical Trial Operational Experience: at least 3-5 years clinical trial operational experiences
• Cross-Functional Collaboration Experience: Proven experience in cross-functional communication and
• coordination, working effectively across multiple departments. Strong influencing, motivational,
• interpersonal, and relationship-building skills.
• Strategic and Critical thinking: Good mindset and ability to analyze complex situations, anticipate
• challenges, and devise effective plans for achieving long-term objectives through informed and innovative
• decision-making skills.
• Leadership and Communication Skills: Strong leadership and communication skills to manage teams and
• engage with various stakeholders effectively.
• Excellent written and oral communication skills in English.
• Strong computer skills and knowledge of systems such as CTMS, Vault, SolTraqs, etc.
• Key Stakeholders:
• Country COM, COM, RDQA, QMTC, CPC.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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