Associate Director, Clinical Quality Assurance, Rare Genetic & Hematology (Remote)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.



Job Description



Job Title: Associate Director, Clinical Quality Assurance, Rare Genetic & Hematology (Remote)



Location: Cambridge, MA (Remote)



About the role:

Responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.

Provide professional expertise and guidance on Good Clinical Practice (GCP), medical device regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations

Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.

Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors



How you will contribute:

Provide expertise in GCP and medical device compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams

Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures

Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities

Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions

Assess and improve our overall processes and systems for utilizing medical devices in clinical trials

Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation

Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups

Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution

Participate in due diligence activities and process improvement initiatives, as requested by management

Assume complex assignments on issues or studies where there is no precedent

Mentor and provide support to Manager level CQA personnel, as needed

May act as a supervisor for temporary contractors



What you bring to Takeda:

BA/BS degree required; advanced degree preferred.

Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.

Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience.

Extensive knowledge and/or awareness of ICH GCP, medical device and applicable global regulations and guidance for clinical development

Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems

Strong technical writing skills; able to write quality positions, audit reports, and procedures.

Excellent communication skills with ability to negotiate and influence without authority in a matrix environment

Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines

Superior attention to detail and ability to analyze complex data

GCP Quality Assurance registration/certification preferred

Routine demands of an office-based environment

Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.

Requires approximately 15% travel.



What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision

Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Professional training and development opportunities

Tuition reimbursement



Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:



Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

Work in a cold, wet environment.

Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.



More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.



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.



This posting excludes Colorado applicants.



Base Salary Range: $143,500 - $199,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.



#GMSGQ



#ZR1



#LI-MA1



EEO Statement



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.



Locations



Massachusetts - Virtual



Worker Type



Employee



Worker Sub-Type



Regular



Time Type



Full time



#LI-Remote