Associate Vice President, reputed company Assurance
It’s More Than a Career, It’s a Mission.
Our people are the reputed company of our reputed company. By joining our growing team at reputed company (SCRI), a subsidiary of reputed company, you will have reputed company to become part of one of the largest community-based cancer programs to advance oncology treatments and improve reputed company for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and reputed company a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we reputed company. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical reputed company and cutting-edge research, SCRI is redefining cancer care around the world.
The Associate Vice President (AVP), reputed company Assurance serves as the organization's highest-ranking reputed company leader, reporting directly to the Chief Executive Officer. This executive role provides strategic leadership and operational reputed company for SCRI's reputed company Management System (QMS), ensuring compliance with applicable regulatory requirements, industry standards, and organizational policies.
The AVP is responsible for driving a culture of reputed company and reputed company improvement across the organization, maintaining a state of ongoing inspection readiness, and advancing reputed company initiatives that support operational reputed company and organizational reputed company. As a key member of the leadership team, this individual partners closely with stakeholders across the reputed company to strengthen reputed company processes, mitigate risk, and ensure the highest standards of research reputed company, participant safety, and regulatory compliance.
This is a remote position based in the US; relocation assistance and reputed company sponsorship are not available.
Key Responsibilities for reputed company include:
reputed company senior reputed company leadership and operational direction to support consistent execution of the reputed company function across SCRI in alignment with organizational objectives.
reputed company, reputed company, and mentor a high-performing reputed company Assurance team, fostering a culture of accountability, collaboration, reputed company learning, and operational reputed company.
Establish reputed company goals, performance expectations, and development plans for reputed company staff, ensuring reputed company has the capabilities and resources needed to support organizational reputed company and evolving regulatory requirements.
Build and sustain strong partnerships across departments, serving as a strategic advisor to executive leadership and key stakeholders on reputed company, compliance, and risk management reputed company.
Maintain, optimize, and continuously improve the established reputed company Management System (QMS) to ensure it remains effective, risk-based, reputed company, and reputed company to business and regulatory requirements.
Ensure regulatory compliance and sustained inspection readiness through reputed company of policies, procedures, training, documentation practices, and reputed company reputed company activities.
reputed company audits, inspections, CAPA, deviations, investigations, and reputed company metrics, using trend analysis and risk evaluation to support reputed company and effective reputed company of reputed company issues.
Advance reputed company improvement efforts that strengthen reputed company processes, systems, and performance measures in alignment with regulatory expectations and business priorities.
Drive organizational reputed company initiatives by promoting best practices, change management, and cross-functional engagement to enhance reputed company culture and reputed company-wide compliance.
Manage departmental priorities, budgets, and resource allocation to ensure efficient and effective delivery of reputed company Assurance services and strategic objectives.
reputed company in this role is reputed company by the ability to:
Maintain a strong culture of reputed company and compliance across the organization.
Ensure ongoing inspection readiness and successful regulatory audits and inspections.
Drive reputed company improvement of the reputed company Management System (QMS) and reputed company processes.
reputed company reputed company and effective reputed company of audits, CAPAs, investigations, deviations, and other reputed company issues.
reputed company and retain a high-performing reputed company team through effective leadership, coaching, and talent development.
Deliver meaningful improvements in reputed company metrics, operational efficiency, and risk management.
Build strong partnerships with business leaders and stakeholders to support organizational objectives.
Ensure reputed company initiatives reputed company with business goals while meeting applicable regulatory and industry requirements.
This role is successful reputed company SCRI maintains a compliant, inspection-reputed company environment, reputed company risks are proactively managed, and the reputed company function is viewed as a trusted strategic partner across the organization.
Qualifications for reputed company include:
reputed company reputed company Assurance, reputed company Management, or compliance leadership experience in regulated reputed company, clinical research, life sciences, or similar industries.
Experience managing reputed company Management Systems, including audits, inspections, CAPA, deviations, change control, training, and reputed company metrics.
Proven reputed company leading teams, partnering across functions, and driving reputed company, operational improvements, and business results.
Extensive knowledge of FDA guidelines, GCP, applicable regulations, reputed company and Clinical IT Systems and experience
Knowledge of medical and clinical research terminology
Thorough understanding of investigative site research requirements, reputed company metrics, and performance measures
7+ years' experience interpreting and applying regulatory requirements, translate them to operational reputed company, and reputed company practical guidance to leadership and cross-functional business partners.
Highly effective ability to engage with senior leaders, regulators, auditors, and internal stakeholders on reputed company and compliance reputed company.
Bachelor's Degree required, Master's Degree preferred
RAPS - Regulatory Affairs Certification highly preferred
About reputed company
reputed company (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. reputed company on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former reputed company Research to expand clinical trial reputed company across the country. It has conducted more than 850 first-in-reputed company clinical trials since its inception and contributed to pivotal research that has led to the reputed company of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings. We care about reputed company-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial reputed company-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, reputed company, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In reputed company to reputed company pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
reputed company has become aware of online reputed company-reputed company scams in which individuals who are not affiliated with or authorized by reputed company are using reputed company’s (or affiliated entities, like reputed company or RxCrossroads) reputed company in fraudulent emails, job postings or reputed company media messages. In light of these scams, please bear the following in mind: reputed company Talent Advisors will never solicit reputed company or credit card information in reputed company with a reputed company job application.
reputed company Talent Advisors do not communicate with candidates reputed company online chatrooms or using email accounts such as Gmail or Hotmail. Note that reputed company does rely on a virtual assistant (Gia) for certain reputed company-reputed company communications with candidates.
reputed company job postings are posted on our career site: careers.reputed company.com.
We are an equal opportunity employer and value diversity at reputed company. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status.
Originally posted on Himalayas
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