Senior GCP Supplier Quality Manager (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 DescriptionJob Title: Senior GCP Supplier Quality Manager (Remote)Location : Cambridge, MAAbout the role:

Develop and implement the GCP supplier audit plan for clinical development programs and studies

Oversee audits for strategic partners and key GCP suppliers

Manage and escalate identified compliance risks, ensuring appropriate mitigations are implemented

Lead and/or participate in GCP sponsor and supplier oversight initiatives

Provide professional expertise and leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk to R&D Business Partners and Takeda

How you will contribute:

Provide professional expertise and leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk for suppliers

Develop and implement the risk-based GCP supplier audit and compliance strategy and manage supplier audits 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

Provide support as needed for quality governance council meetings

Liaise and collaborate with internal Takeda and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives

Analyze audit metrics and develop reports for management

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

Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues

Lead process improvement initiatives as requested by management

Participate in GCP health authority inspections, as required

What you bring to Takeda:

Bachelor’s Degree required; Advanced Degree preferred

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

Minimum 5 years GCP auditing or relevant clinical trial experience preferred

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 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 20-30% 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 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.

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-MA1EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote