Job Title: Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies (Remote)
Location: Cambridge, MA
About the role:
As the Senior Program Manager for Plasma Derived Therapies, you will lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. You will have a depth of experience in GCP and compliance and leadership to provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to identify compliance issues/risks and recommend mitigations. You will report to the Head of Oncology and Cell Therapy, Clinical Quality Assurance.
How you will contribute:
You will partner with several 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 allow teams to be inspection ready, to support a culture of sustainable compliance.
You will 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
- You will provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership.
- You will 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 procedures. Audits require advanced auditing skills and may involve technically complex assignments.
- You will 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.
- Facilitate investigations into quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Help manage 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 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:
You will need a BS/BA required; Advanced Degree preferred.
You will need 7 years of experience in the pharmaceutical, biotechnology or related health care industry.
You will need 5 years of GCP-related Quality Assurance or relevant clinical trial experience.
You will have great Understanding of ICH GCP R2 and applicable global regulations and guidance for clinical development
You will have 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.
You will need technical writing skills; able to write quality positions, audit reports, and procedures.
Project management experience with the ability to manage projects with demanding timeline
GCP Quality Assurance registration/certification would be ideal
Remote role with quarterly travel to the office for meetings, audits and inspections, including overnight trips. Some international travel may be required. Requires approximately 10% travel or less.
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
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 environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
- 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.
- Must be able to work multiple shifts, including weekends.
- Non-Exempt Roles only: Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- Routine demands of an office-based environment
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.
#GMSGQ #ZR1 #LI-MA1 #LI-Remote
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, MAWorker Type