AbbVie R&D QA Manager (AREA) in Sydney, Australia
R&D QA Manager (AREA)
Australia, New South Wales, Sydney
1 additional location
Australia, New South Wales
As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product in order to achieve product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D global trial footprint has been expanding over the last several years due to growth in the pipeline and the complexity of global development resulting in an overall increase in countries conducting global trials. It’s crucial that proactive quality foundations be established and maintained through a focus of continuous improvement supported locally by RDQA employees through a hub concept supporting a group of Affiliates within the designated AREA.
RDQA AREA has been implemented with the focus of building quality into R&D functions within a designated hub of Affiliates supporting AbbVie clinical trials. The new role of RDQA AREA Manager has been developed and will report to the RDQA AREA Head. Initial scope includes R&D, clinical development activities associated with investigational medicinal product (IMPs) clinical trials conducted globally for market authorization. Expected results are first pass approvals thereby ensuring access to innovative therapies by patients and advancing the pipeline.
This role will be responsible for the implementation/execution of activities related to proactive quality management within Affiliates as assigned by RDQA AREA Head.
Maintain a close, collaborative relationship with RDQA functions impacting clinical research activities including clinical trials within designated Affiliates in the 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 regulations.
Lead and/or collaborate on development of risk identification and risk mitigation or control strategies for clinical research activities including clinical trials within designated Affiliates in assigned AREA.
Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy in designated AREA in conjunction with other RDQA AREA personnel. Manage governance/oversightthat 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 issues that impact clinical research.
Implement quality surveillance program in conjunction RDQA AREA Head 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.
Develop Key Performance metrics (leading and lagging indicators) to measure quality and compliance and drive continuous improvement measures with stakeholders in Affiliates. Involvement in periodic reviews of quality and compliance data for the purposes of continuous improvement.
Ensure consistent understanding of the quality requirements for clinical research activities within Affiliates, works closely with Affiliates R&D Management on health of Quality System, identifies 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 relating to 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.
Develop inspection strategy in collaboration with AREA Head and relevant functions and provide inspection-readiness support for all local Health Authority inspections. Provides governance, oversight, support and follow-up (inspection report response) for local Health Authority inspections with employees and management in AREA Affiliates. Participation in local Health Authority inspections will be ‘fit for purpose’ and determined by need.
Determine need for assessments, in collaboration with RDQA program management and others, to determine need for specific audits.
Conduct audits as required to assess compliance with regulations, guidelines, policies, procedures and Sponsor requirements. Effectively communicate audit results, both orally and in writing. Review and approve corrective action plans/audit responses.
Support the development of robust audit and inspection responses through coaching and education.
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.
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. 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.
Excellent communication (written and oral) skills.
Strong negotiation, influencing and collaborating abilities with excellent networking skills. Ability to foster cross functional collaboration teams.
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.
7+ years of biopharmaceutical industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions that includes 3 years in leadership positions (people and/or initiatives/projects).
Ability to travel as needed in AREA (up to 35%).
Fluent in additional languages desirable but not required.
- RDQA, Site Management & Monitoring, Clinical Program Development, , AREA-Affiliates including Clin Research, Regulatory, Patient Safety, Affiliate GM and Staff
Job Type: Experienced