- Develop, implement, and ensure continuous improvement of the clinical quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices.
- Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
- Drive effective and efficient execution of clinical quality assurance projects/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and continuous improvement efforts.
- Pioneer industry leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across GCP activities.
- Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
- Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
- Consult and partner with the R&D Quality Internal Audit team to ensure appropriate focus areas of clinical operations, including investigator sites, vendors, and internal processes. Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.
- Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
- Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external/internal requirements including seamless integration with R&D and Executive Management review.
- Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and auditors.
- Drive a culture of continuous improvement in clinical quality assurance. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance.
- Evolve, develop, lead, guide, and mentor a growing geographical dispersed clinical quality assurance team, responsible for the execution and sustainability of GCP across the R&D clinical trial/study portfolio. Set clear expectations, manage performance, and foster a positive collaborative working environment for a geographically diverse team located around the world. Develop talent and build a skilled motivated team.
- Bachelor's degree required, preferably in Biology, Chemistry, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience.
- 15+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, quality systems, or a combination of those or comparable experiences. Tactical and strategic clinical quality assurance experience required. Quality assurance, quality systems, and/or quality compliance background experience are highly desirable.
- Thorough understanding of global and local clinical trial/study regulatory requirements and processes in multiple disciplines (Pharma and Medical Device). Must be able to make critical, creative, and strategic decisions as a result of rapid analysis of available information. This must include thorough risk-assessment for the integrity of the product, patient rights/safety, and for the business. Thus, a balance must be maintained between quality and productivity
- 10+ years leadership experience and exemplary tactics in motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive information and situations.
- Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment. Ability to motivate and develop high-performing teams with challenging goals that bring growth and development.
- Strong leadership presence and effective decision making required. Strategic, creative, and "big picture" thinker, considered a visionary. Proactive leader with well-developed leadership skills and the ability to anticipate and identify potential issues to address early to mitigate or prevent. Demonstrated executive presence. Ability to make difficult decisions under pressure.
- Ability to direct and coach all aspects of work projects (strategic and tactical) effectively within evolving and at times rapidly changing priorities and deadlines.
- Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal and external stakeholders.
- Evaluates performance, ability to differentiate various performance levels, and assists in career development planning for employees within responsibility.
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Head of Clinical Quality Assurance - North Chicago, United States - AbbVie
Description
Company DescriptionAbbVie'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 Follow [redacted] on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people's lives. As a quality organization in research & development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product's lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie's evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs. An elevated, focused, and evolved Good Clinical Practices (GCP) strategy and pipeline partnership are essential. The Global Head/Vice President Clinical Quality Assurance is a key role in R&D, responsible for leading the Clinical Quality Assurance function and partnering with AbbVie's R&D Clinical Development organization to achieve consistent high-quality clinical research outcomes.
The Global Head Clinical Quality Assurance provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). The role collaborates with R&D clinical development senior leaders and stakeholders to develop, implement, and continuously improve global and local GCP quality strategies that align with AbbVie R&D pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
This role reports directly to the Vice President of R&D Quality Assurance and is a member of the R&D Quality Leadership Team. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.
Major Responsibilities:
Qualifications
Qualifications:
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
