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Job Title: Program Manager, Clinical Quality Assurance

Location: Cambridge, MA

About the role:

• Lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires sufficient understanding, experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with supervision.
• 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.
• Provide expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations

• 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.

How you will contribute:

• 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
• Perform additional GCP related activities upon request by CQA management
• Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, Takeda sites, or functional groups.
• Under supervision, provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership
• Provide GCP compliance support during inspections of investigator sites and Takeda. Assist with development of appropriate and timely inspection responses and follow-up actions
• Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
• Assist with 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.
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Under supervision, 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.

What you bring to Takeda:

• Knowledge of 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.
• GCP Quality Assurance registration/certification preferred
• Collaborative team player with a positive attitude
• Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
• Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
• Routine demands of an office-based environment
• BS/BA degree required; advanced degree preferred.
• Effective technical writing skills; able to write quality positions, audit reports, and procedures.
• Superior attention to detail and ability to analyze complex data
• Strong communication skills with ability to negotiate and influence without authority in a matrix environment
• Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
• Requires approximately 30% travel.
• Knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development

What Takeda can offer you:

• Tuition reimbursement
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Comprehensive Healthcare: Medical, Dental, and Vision
• Professional training and development opportunities
• Family Planning Support
• Community Outreach Programs and company match of charitable contributions
• Generous time off for vacation and the option to purchase additional vacation days
• Health & Wellness programs including onsite flu shots and health screenings

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:

• Some Clean Room and cool/hot storage conditions.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold and/or wet environment.
• Non-Exempt Roles only: Must be able to work overtime as required.
• Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• Must be able to work multiple shifts, including weekends.
• May be required to work in a confined area.

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.

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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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time