External Supply Quality Lead (Associate Director) at Takeda Pharmaceuticals U.S.A., Inc in Lexington, Massachusetts

Job Description:

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Job Description

Position Title: External Supply Quality Lead (Associate Director)

Reports to: Head of External Supply, US Quality

Location: Lexington, MA - This is a Hybrid Workplace Position

About the role:

You will have responsibility for the Quality Assurance for commercial Drug Products (DP).

The leader in this role will have Quality oversight of strategic DP suppliers for Takeda. You will review deviations, change controls, and validations for Takeda DP's, and manage/attend periodic business reviews with the CMOs. You will also manage Quality metrics and CMO performance. Drug Products manufacturing and Quality System knowledge are required for this role. You will establish the strategy and plans for the ESQL Quality organization to meet the Quality and OpU vision and goals, establish priorities, implement Quality Improvement projects, and manage the finances of the team.

How you will contribute:

• Accountable for the product quality performance at designated CMOs.


• Responsible for product quality performance through product and supplier Quality Risk Management and ensuring an environment of continuous improvement.


• Accountable for supplier quality management practices to support the outsourced manufacturing and testing model in the respective regions.


• Create a clear and unifying vision for the ESQL area to assure product and process compliance. Foster enthusiasm and commitment to the unifying vision within the team.


• Define and promote the implementation of compliance strategies, quality plans, and Commercial Quality Assurance programs for managing Takeda outsourced material procurement, and product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products.


• Independently and directly represent Takeda to make decisions on the acceptability of quality programs, and ongoing activities at the CMO.


• Establish quality and compliance expectations for CMOs and CTLs; perform strategic systems reviews and coordinate risk and benefit analyses of supplier's processes.


• Work with specific Takeda LOCs to assure compliance with country-specific regulations.


• Work with ESQL team to lead audits of CMOs or CTLs, including development or audit reports and review of the acceptability of CMO/CTL corrective actions.


• Provide leadership and oversight in the assessment of important changes or deviations for Takeda products.


• Ensure successful completion of all product submissions, launches, validations, and new Takeda projects within Takeda, and at our contract manufacturing sites.


• Help with FDA or other regulatory inspections of Oncology, Small Molecule External Supply, other Takeda facilities, or third-party suppliers associated with the commercial product supply chain.


• Identify important trends and new issues at suppliers and implement corrective actions.


• Able to travel 20% (domestic)

Technical/Functional (Line) Expertise:

• Knowledge of Takeda's strategy and performance and using that information to anticipate long-range planning for products

Decision-making and Autonomy:

• Budget accountability for the Regional Quality Onc ESSM ESQL lane

Interaction:

• Work with partners, regulators, industry peers, and other Takeda quality units.

Innovation:

• Contribute thought and experience supporting the development of an External Network Quality Strategy to meet the Quality Roadmap.

Complexity:

• Accountable for Quality performance at strategic CMO's supporting Takeda's primary business, and managing high-complexity supply chains.

What you bring to Takeda:

Essential Experience & Education:

• A Bachelor's Degree in Pharmacy, Chemistry, Biology, or a similar discipline


• 12 years of QA/QC experience in the pharmaceutical industry, and QA/QC laboratory environment.


• 10+ years of increasing management responsibility combined with technical operations background.


• Experience with global Health Authorities' requirements in the GMP and GDP regulated area; detailed knowledge of EU GMP, PIC/S, ICH, and other relevant regulations.

Desired Skills:

• At least 6 years of people management experience.


• Project Management expertise

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 charitable contributions


• Family Planning Support


• Professional development opportunities


• Tuition reimbursement

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 which 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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time