Senior Program Manager, Clinical Quality Assurance...

Boston, MA, United States

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Job Description

Job Title: Senior Program Manager, Clinical Quality Assurance, Gastrointestinal & Inflammation (Remote)

Location : Cambridge, MA

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 experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with minimal supervision.

• Provide professional expertise and guidance on Good Clinical Practice (GCP) and… 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.

• 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 compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership

• 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 may 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

• Facilitate 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.

• Assist with management of 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.

• 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.

• Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.

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

• Perform additional GCP related activities upon request by CQA management

What you bring to Takeda:

• BS/BA required; Advanced Degree preferred.

• Minimum of 7 years of experience in the pharmaceutical, biotechnology or related health care industry.

• Minimum 5 years of GCP-related Quality Assurance or relevant clinical trial experience.

• Extensive knowledge and/or awareness of ICH GCP R2 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

• Effective 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 analyse complex data

• GCP Quality Assurance registration/certification preferred

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

• Requires approximately 30% travel.

PHYSICAL DEMANDS:

• Routine demands of an office-based environment

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.

Base Salary Range: $130,200 to $186,000. 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.

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

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