Associate Director, Clinical Quality Compliance Specialist
12 hours ago
We are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.
You will maintain a state of control by implementing monitoring and control systems that ensure our quality systems supporting clinical trial delivery are aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, managing operational activities, and building capabilities within the GCP Compliance function.
Key Responsibilities- Partner with different functions to identify systemic quality and compliance risks, conduct investigations, and develop adequate corrective and preventive actions (CAPAs)
- Lead the clinical trial delivery system inspection readiness program, including implementing a strategy and engaging with relevant responsibilities and partners to ensure inspection readiness
- Provide insights to latest requirements, operational and compliance metrics, and storyboards, identify quality and compliance inspection risks, and provide tactical directions in mitigation
- Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SMEs)
- Ensure a communication plan is in place to enable knowledge sharing of insights and risks, communicate the progress of inspections daily, and timely escalate to management
- Lead the inspection response activities, ensuring responses are adequate, reviewed, and approved internally by relevant partners, and submitted on time
- Provide input to responses to ensure the impact is thoroughly assessed, appropriate cause is identified, and measurable, achievable, time-bound CAPAs are developed
- Oversee the completion and closure of inspection CAPAs, ensuring no inspection CAPAs are late, mitigate and escalate any risks, and ensure appropriate effectiveness checks are developed for relevant inspection CAPAs
- Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality investigation, CAPA management, and oversight, and represent Clinical Quality Compliance in these topics in inspections
- Support and provide relevant guidance to other non-GCP specific inspections (e.g., GVP, GMP)
- Lead complex quality investigations to improve clinical trial delivery systems, provide Quality Leadership for other quality investigations, and develop lessons learned from regulatory inspections and quality investigations
- Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI), mitigate, communicate, and escalate any risks flagged by the metrics/KQIs, and drive the development and execution of the strategy to understand the health of the clinical trial delivery quality system
- Contribute to relevant quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements, and successes
- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance
- Experience with pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH
- Experience in successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, and remediation activities on a global level
- Experience in managing complex organizational compliance issues and implementing organization-wide compliance projects
Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
At Takeda, we are committed to equitable pay for all employees and strive to be more transparent with our pay practices.
We offer a competitive salary range of $149,000 to $234,300.00, depending on qualifications and experience. U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
Employees are also eligible to receive up to 80 hours of sick time and accrue up to 120 hours of paid vacation per calendar year.
Takeda is proud of 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.
-
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob DescriptionVertex Pharmaceuticals is seeking a highly skilled Associate Director, CMC Compliance to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of our vendors with regulatory requirements.Key Responsibilities:Develop and maintain a comprehensive vendor quality management...
-
Compliance Quality Assurance Director
2 weeks ago
Boston, Massachusetts, United States AIG Full timeJob Title: Compliance Quality Assurance DirectorAIG is seeking a highly motivated and results-oriented Compliance Quality Assurance Director to join our team. As a key member of our Compliance Department, you will be responsible for developing and implementing a comprehensive Quality Assurance & Market Conduct Review process to ensure compliance with...
-
Compliance Director
4 days ago
Boston, Massachusetts, United States InsideHigherEd Full timeCompliance Director Job DescriptionBoston University's Compliance Services Office (CSO) is seeking a highly motivated and collaborative compliance professional to join its University-wide compliance office.The Compliance Director will provide critical leadership, development, implementation, facilitation, and coordination of Boston University's Compliance...
-
Clinical Specialist
2 weeks ago
Boston, Massachusetts, United States Mass Inc Full timeAbout the RoleThe Office of the Child Advocate (OCA) is seeking a highly skilled Clinical Specialist to join its Quality Assurance Team. As a key member of the team, you will play a critical role in ensuring the quality of state services provided to children and families.Key ResponsibilitiesPerform ombudsperson functions on the OCA Complaint Line, responding...
-
Compliance Director
2 weeks ago
Boston, Massachusetts, United States InsideHigherEd Full timeCompliance Director Job DescriptionBoston University's Compliance Services Office (CSO) is seeking a highly motivated and collaborative compliance professional to join its University-wide compliance office.The Compliance Director will provide critical leadership, development, implementation, facilitation, and coordination of Boston University's Compliance...
-
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryThe Associate Director, GDP Operational Quality role is responsible for ensuring that medicines are distributed in the US in compliance with GDP and GMP requirements. This position will work with the GDP Operational QA Management team to maintain the quality of products and ensure compliance with regulatory requirements.Key ResponsibilitiesManage...
-
Compliance Quality Assurance Director
3 weeks ago
Boston, Massachusetts, United States AIG Full timeJob SummaryWe are seeking a highly motivated and results-oriented Compliance Quality Assurance Director to join our team at AIG. As a key member of our Compliance Department, you will be responsible for developing and implementing a comprehensive Quality Assurance and Market Conduct Review process to ensure compliance with regulatory requirements and company...
-
Clinical Specialist
1 day ago
Boston, Massachusetts, United States Mass Inc Full timeAbout the PositionThe Quality Assurance Team at Mass Inc focuses on enhancing the quality of state service delivery by responding to individual concerns about children received via our Complaint Line and evaluating statutorily required critical incident reports and supported reports of abuse and/or neglect of children in out-of-home settings.In addition to...
-
Compliance Quality Assurance Director
4 weeks ago
Boston, Massachusetts, United States AIG Full timeJob SummaryAIG is seeking a highly motivated and results-oriented Compliance Quality Assurance Director to join our team. As a key member of our Compliance Department, you will be responsible for developing and implementing a comprehensive Quality Assurance & Market Conduct Review process to ensure compliance with regulatory requirements and industry...
-
Clinical Development Associate Director
1 week ago
Boston, Massachusetts, United States CRISPR Therapeutics Full timeJob Title: Associate Director/Director, Clinical DevelopmentCRISPR Therapeutics is seeking a highly skilled Associate Director/Director, Clinical Development to join our team. In this role, you will provide clinical and scientific input to early-stage clinical development programs, contributing to the scientific development of individual clinical studies and...
-
Compliance Specialist
3 weeks ago
Boston, Massachusetts, United States Cambridge Associates LLC Full timeThe Compliance Associate RoleAt Cambridge Associates LLC, we are seeking a highly skilled Compliance Associate to join our team. As a key member of our compliance department, you will play a critical role in ensuring the firm's compliance with regulatory requirements and industry standards.Key Responsibilities• Develop and implement compliance programs and...
-
Director, FDAS Compliance
8 hours ago
Boston, Massachusetts, United States Fidelity Investments Full timeJob Title: Director, FDAS ComplianceAt Fidelity Investments, we are seeking a highly skilled and experienced Director, FDAS Compliance to join our team. As a key member of our Compliance department, you will play a critical role in ensuring that our digital assets business operates in compliance with all relevant regulations and laws.Key...
-
Clinical Specialist
2 weeks ago
Boston, Massachusetts, United States Mass Inc Full timeAbout the PositionThe Office of the Child Advocate (OCA) is an independent executive branch agency with oversight and ombudsperson responsibilities, established by the Massachusetts Legislature in 2008.The OCA's mission is to ensure that children receive appropriate, timely, and quality state services, with a particular focus on ensuring that the...
-
Boston, Massachusetts, United States Boston University Full timeJob Title: Associate Director, Fund Stewardship and Compliance Boston University is seeking an experienced Associate Director to join our Development and Alumni Relations team. This role will play a critical part in ensuring the effective management of restricted funds, ensuring compliance with donor restrictions, University policy, and industry...
-
Boston, Massachusetts, United States Boston University Full timeJob Title: Associate Director, Fund Stewardship and Compliance Boston University is seeking an experienced Associate Director to join our Development and Alumni Relations team. This role will play a key part in ensuring the effective management of restricted funds, working closely with academic and financial partners to promote compliance and integrity in...
-
Associate Director, Clinical Trial Liaison
1 week ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Title: Associate Director, Clinical Trial LiaisonVertex Pharmaceuticals is seeking an experienced Associate Director, Clinical Trial Liaison to join our team. As a key member of our Clinical Development organization, you will be responsible for building and maintaining relationships with clinical research sites, therapeutic area networks, and other...
-
Compliance Director
16 hours ago
Boston, Massachusetts, United States Fidelity Investments Full timeJob Summary:About the Role:Fidelity Investments is seeking a highly skilled Compliance Director to join our Fidelity Digital Assets team. As a key member of our Compliance team, you will play a critical role in promoting a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.Key Responsibilities:Lead the Regulatory...
-
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryVertex Pharmaceuticals is seeking an experienced Associate Director to lead the Quality Operations team in our Cell and Gene Manufacturing department. The successful candidate will be responsible for ensuring the quality and compliance of our manufacturing processes, as well as developing and implementing continuous improvement initiatives.Key...
-
Boston, Massachusetts, United States InsideHigherEd Full timeJob Title: Associate Director, Fund Stewardship and ComplianceWe are seeking an experienced Associate Director to join our Stewardship and Donor Relations team at Boston University. The successful candidate will play a key role in refining a comprehensive, donor-centric strategy around fund management, working closely with our Stewardship and Donor...
-
Boston, Massachusetts, United States InsideHigherEd Full timeJob Title: Associate Director, Fund Stewardship and ComplianceWe are seeking an experienced Associate Director to join our Stewardship and Donor Relations team at Boston University. The successful candidate will play a key role in refining our comprehensive, donor-centric strategy around fund management, working closely with our Stewardship and Donor...
