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Director, GCP Compliance - REMOTE
Lead/drive development and implementation of compliance management for clinical trial delivery including quality event determination and documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
Establish and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources; establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies.
Develop, lead and drive clinical trial delivery metrics and reporting including but not limited to training and CAPA completion compliance
Proactive GCP Oversight
Establish, build and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources
Partner with R&D QA on GCP compliance strategy; collaborate and enable multilevel corrective and preventative actions with QA, Process Training and Digital Solutions, and cross functional clinical trial delivery functions
Establish, build and manage proactive compliance project management team to plan, implement, manage and report processes to determine adherence and understanding of ICH GCP requirements and Takeda processes
Provide near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
Identify, strategize and facilitate solutions to identified areas of concern with cross functional clinical trial delivery stakeholders
GCP Compliance Metrics and Reporting
Establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies to track process quality and compliance
Partner with clinical trial delivery functions, R&D QA and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
Oversee direct reports and/or functional service providers on GCP metrics and analytics team
Develop strategy and implementation plan for development and maintenance of KPIs, metrics and dashboards to track process quality and compliance
GCP Quality Liaison
Establish compliance GCP Quality Liaison network responsible for clinical trial delivery deviation and CAPA management including deviation determination, documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed
Srategize and lead study teams and functional areas in CAPA definition for deviations, audits and inspections.
Manage CAPA reporting for clinical trial delivery and facilitate leadership review; work with functional areas to solve compliance gaps
Lead compliance and oversight for GCP Quality Plan; strategize and collaborate with R&D QA on next steps and actions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor's Degree or international equivalent required, Life Sciences preferred
10+ years experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in clinical study management, including at least 6 years of line management experience
Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams
Strong strategic thinking, planning, execution, and communication skills
Global/international experience required, including ability to collaborate with colleagues and staff in other locations
Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development
Health care business acumen with a comprehensive understanding of the pharmaceutical industry
Base Salary Range: $160-229K. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts - VirtualWorker Type
Full time #LI-Remote$160k-229k yearly1d ago
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Average Salary For a Compliance Manager
Based on recent jobs postings on Zippia, the average salary in the U.S. for a Compliance Manager is $95,130 per year or $46 per hour.
The highest paying Compliance Manager jobs have a salary over $136,000 per year while the lowest paying Compliance Manager jobs pay $66,000 per year
Directors work in show business, whether in a film, a television show, or a theatre production. They are responsible for bringing the material to life. They work with the writers to get a clear vision of how the production should look. They lead the production team in planning for the production, identifying filming or rehearsing schedules, casting for roles, and other aspects that need to be decided upon. Directors provide direction to the actors to ensure that the actors understand their role and will be able to effectively convey emotions to the audience. They also manage all other crew members and communicate their expectations clearly so that everyone on the set is working towards one vision.
Senior project managers are experienced employees assigned to oversee a specific project in the organization. They manage the project from conception to execution. They are onboard the project from the ideation phase, providing valuable insights to ensure the success of the project. Senior project managers are also in charge of managing the budget, ensuring that the expected timelines are followed, adjusting strategies when needed, and guiding project team members. It is important for senior project managers to be good leaders and communicators. They should be able to balance the interests of all the stakeholders involved in the project. They should have good interpersonal skills and decision-making skills.
Owners, in the most basic sense, own the business, company, or organization. They are responsible for building the business. They create business plans and the general vision and mission of the company, set goals, work on these goals, and ensure that the business keeps running. They manage all aspects of their business, from finances to marketing to people, etc. When the business becomes stable, owners eventually hire more employees. As such, owners also become overseers who would ensure that the organization remains afloat.
A senior manager is responsible for directing the overall efficiency of business operations. Senior managers monitor the performance of the staff, improve operational strategies, identify business opportunities, allocate budgets and resources, present reports to senior management, set goals to drive results on increasing the company's revenues and profitability. Senior managers must coordinate with various operations departments to maintain good feedback for the company, meeting client's expectations, and delivering the best results. They should have excellent communication and leadership skills to handle team members, as well as managing their needs and concerns.
A regulatory compliance manager is responsible for evaluating the company's processes and procedures, ensuring that everything adheres to the internal guidelines and state regulations. Regulatory compliance managers write reports of observational findings, conducting audits on policies, and taking disciplinary actions for violations. They also facilitate regulatory training and programs to inform the employees of the company's procedures to avoid hazards and complications in the workplace. A regulatory compliance manager analyzes incident reports and complaints statements, resolving compliance issues immediately to avoid further reputational damage for the company.
To become a good compliance manager requires both mandatory education and, in many cases, certifications. Compliance managers work in many different industries and must learn the specific rules and regulations of the industry in which they work.
The qualifications you need to be a compliance officer are a bachelor's degree and demonstrating an appropriate skill set. There are no current accredited degrees for compliance; however, a degree in criminal justice, business management, or finance are all preferred modes of entry for budding compliance officers.
Compliance managers should possess the skills of leadership, communication, and a deep understanding of the law. Because compliance managers work in various industries, they must be aware of industry-specific regulations.