AbbVie RDQA Area Manager - JAPAC in Shanghai, China
RDQA Area Manager - JAPAC
China, Shanghai, Shanghai
1 additional location
This role will be responsible for the implementation/execution of activities related to proactive quality management and independent audit in Affiliates as assigned by RDQA AREA Head. Maintain a close, collaborative relationship with RDQA functions impacting clinical development activities including clinical trials within designated Affiliates in assigned AREA.
Establish collaborative-working relationship with clinical development leaders and staff within designated Area/ Affiliates in order to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
Oversight of quality and compliance in a regulated environment including AbbVie policies and procedures and country specific and other applicable standards and worldwide regulations.
Leads and/or collaborates on development of risk identification and risk mitigation or control strategies for clinical development activities including clinical trials within designated Affiliates in assigned AREA.
Establish quality measures with the desire to achieve RDQA quality goals. Drives quality strategy in designated AREA in conjunction with other RDQA AREA personnel. Manages governance/oversight that is “fit for purpose” and in relation to the One AbbVie Quality System. Identify trends, root causes, and potential risks in order to mitigate and/or prevent that impact clinical development enterprise in work executed by Affiliate.
Implements quality surveillance program in conjunction RDQA Area to assess potential quality risks, including data integrity issues and drives identification, mitigation and prevention. Identifies/facilitates key quality improvements and innovation. Drives vision of continuous state of regulatory preparedness.
Develops Key Performance metrics (leading and lagging indicators) to measure quality and
compliance and drive continuous improvement measures with stakeholders in Affiliates.
Ensures consistent understanding of the quality requirements for clinical development activities in Affiliates, works closely with Affiliates R&D Management on health of Quality System, issues of quality and compliance that will impact overall goals and desired outcomes.
Ensure that R&D policies, processes and procedures adequately conform to worldwide regulations. Maintain awareness of all ' applicable regulations and develop appropriate standards to measure quality in Affiliate of clinical research.
Ensure regional practices are providing a consistent level of quality and compliance throughout the development of pharmaceutical products and are following AbbVie’s Quality Policies.
Support necessary supplier visits, audits and vendor qualifications within Affiliates, provide oversight for corrective action process as necessary.
Develops inspection strategy for all local external regulatory inspections and provide inspection-readiness support for all internal local inspections
Provides governance, oversight, support and follow-up for Affiliate local heather authority inspections with employees and management in Area Affiliates.
The incumbent will participate in health authority inspections, specific role will be “fit for purpose “and determined by need. Will require inspection prep internal to affiliate as well as investigative sites as necessary.
Will determine need for assessments, in collaboration with program management determine need to specific audits, and execute audits as assigned
Ability to influence with recommendations for prevention and/or remediation strategies for potential gaps, often under a number of constraints (with a clear understanding of their future impact).
The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations.
Must apply critical thinking and be able to formulate decisions and approaches in the complex, matrix world of the clinical research & development with all associated business partners. Strong understanding of local regulatory and legal requirements.
List required and preferred qualifications (up to 10). Include education, skills and experience.
Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. Masters I PhD is desirable but not essential. 10 +years industry experience in any combination of clinical research, pharmacovigilance, Quality Assurance or a combination of those or comparable experiences, including direct people management of a team
Well-developed leadership and collaboration attributes including ability to influence colleagues to bring about alignment, and motivate towards a shared purpose.
Strong analytical skills and the ability to organize work in a logical, through and succinct manner. Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels.
Demonstrates leadership to own toughest challenges, persisting to achieve the right results for the organization as a whole. Motivates and can influence others, including those over whom they have no direct
authority. Professional, accountable, energetic and collaborative team player. Ability to advance or repair relationships within function and business partners.
Thorough knowledge of quality systems, auditing standards and quality management processes.
Advanced business acumen, understands complexities of organizational design, working knowledge of current and future practices
Knowledge of worldwide regulatory requirements and industry best practices that govern clinical development.
Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner. Flexibility to adapt to changing conditions and ability to effectively prioritize. Grasps the “essence” and can change course quickly, where indicated.
Project management, interpersonal, and communication skills with the ability to influence. Strong team player or team lead and builds relationships with peers and cross-functionally at both global and local levels to drive performance.
Extensive knowledge of the clinical development for biopharmaceuticals.
5-7 years of biopharmaceutical industry experience in quality assurance, compliance regulatory affairs and/or other related development functions that includes 3 years in leadership positions (people and/or initiatives/projects)
Ability to travel ( on average 25%) including willingness and ability to perform international travel, if necessary
Excellent communication (written and oral), Influencing and persuasion skills. Ability to build teams.
Fluent in local languages, a plus.
VP R&D QA, GMA EEMEA Area, Regulatory Affairs EEMEA Area Affiliates, Site Management & Monitoring, Clinical Development, PPS