Principal Quality Manager

Job Title : Principal Quality Manager

Interested in this role You can find all the relevant information in the description below.

Location : Cambridge, MA

About the role :

The Principal QA Manager, Cell Therapy Quality (CTQ), you will provide leadership for the day-to-day execution of Quality Assurance activities and implementation of strategies associated with Takeda's cGMP cell therapies manufacturing facility (CTMF) and external partners when applicable.

You will ensure compliance with regulations and Takeda procedures for cGMP manufacturing of clinical-phase cell therapy programs.

You will report to the Director Cell Therapy Product Quality.

How you will contribute :

• Lead the development, implementation, and maintenance of cGMP quality operational processes and continuous improvement efforts that support clinical-phase cell therapies.
• Be a resource for the CTQ organization as a subject-matter-expert across the Quality Assurance discipline and partners with team members and stakeholders in advancing quality and compliance.
• Lead across the site / organization as key GMP Quality Assurance subject matter expert to ensure product quality for clinical-stage programs, compliance with regulations and company procedures, and help achieve business goals.
• Primary contact for resolving quality issues, addressing complex problems, and troubleshooting matters during manufacturing and disposition of critical material, and / or cell therapy products.
• Review manufacturing documents, including master and executed batch records, logbooks, laboratory documentation, and stability reports to ensure compliance and adequacy.

Help with product disposition activities for clinical trials.

• Perform quality assurance walk-throughs for the manufacturing facility, and analytical laboratory, and support internal audits.
• Manage Quality Agreements for Cell Therapy Manufacturing Facility, and ensure audits are completed promptly. Provide Quality oversight and leadership supporting internal manufacturing operations and / or as externally-contracted operations (e.

g., raw materials, drug products, packaging / labeling).

Work across the CTQ team where needed to support manufacturing operations, incoming / materials, equipment & facility matters.

Perform responsibilities in a backup role for other CTQ personnel due to vacation or absences.

• Serve as a key resource for other QA personnel to provide coaching and guidance during routine operations and issue management.
• Work with quality team members and internal stakeholders to support site goals and projects; serve as management back-up / representative where needed.
• Identify quality and compliance gaps, communicate with management, and propose solutions. Lead implementation of endorsed solutions.
• Drive innovation and efficiency by implementing novel ideas and leading optimization projects.
• May support GMP audits of external suppliers.
• Additional duties as assigned.

What you bring to Takeda :

• Bachelor's Degree in Biology, Microbiology, Chemistry or related field is required, Masters Degree preferred.
• 5+ years of experience.
• Working knowledge in biologics, cell or gene therapy product testing, manufacturing and / or development would be ideal.
• Expertise in cGMP requirements associated with biopharmaceuticals, cell therapy, and / or gene therapy.
• In-depth knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond to.
• Experienced with risk management strategies and general project management.
• Experience in identifying and implementing continuous improvement initiatives.
• Proficient in analyzing data to identify performance trends.
• Demonstrated experience providing guidance to stakeholders and peers.
• Advanced negotiating skills.
• Can distinguish between criticalities of quality issues and identify issues or topics for management escalation.
• Manage projects, carries out root-cause investigations, analyzes data, and makes recommendations to management.
• Can read, analyze and interpret common scientific and technical data / reports and legal / regulatory documents.

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 :

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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.
• You will support biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive).

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.

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