Senior QC Manager - Investigations

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Job Title : Senior QC Manager - Investigations

Location : Lexington, MA

About the role:

The Senior Manager's will report to the Associate Director QC Technical Support and will be responsible to lead the QC Investigations team in support of investigations, deviations, change controls, and CAPAs for the Quality Control department. Will conduct investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions observing established procedures and timelines. Focus areas include QC analytical, QC micro, QC raw materials, and cell banking.

The key support services, deliverables, and capabilities within this function include:

• Initiation and closure of deviations, change controls, CAPAs, investigations to support product/raw material disposition and ensure compliance to regulations and procedures

• Preparation and presentation of deviations to leadership and during regulatory inspections and audits

• Managing, coaching and training of junior QC investigators

• Provide subject matter expertise (SME) for investigations

• SME for business processes for investigations, deviations, change controls, and CAPAs for the Site Quality organization

• Support enhancement of Tiered board system, including development and monitoring of metrics intended to guide business process improvements

• Collaboration with peers to drive the alignment of the QC Investigations team's activities across the sites

• Liaise and collaborate with key stakeholders (Manufacturing Investigators, Manufacturing Sciences, Quality Sciences, Analytical Development and Center functions) as applicable

How you will contribute:

• Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Trend (OOT) and unexpected events. Monitor GMP investigations progress and support process to closure. Escalate conflicts that arise.

• Assess and analyze deviations and investigations to determine impact and root cause.

• Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT.

• Identify Quality System and root cause trends and identify opportunities for operational improvements.

• Drive us towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency.

• Continually improve technical expertise and follow company policies/goals/strategies/our results

• Assure productive and focused work / aligned with company and departmental objectives

• Contribute to proactive measures to promote a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports

• Champion self-initiated projects and drive area under their control within the context of functional area priorities

What you bring to Takeda:

• BS/MS Degree in Science or Engineering with a minimum of 8 years of relevant experience

• Proven record of technical leadership, motivate, and lead technical thoughtfulness

• Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies

Key Skills, Abilities, and Competencies

• Strong technical skills and experience in commercial biopharmaceutical Quality/Manufacturing in the areas of analytical testing, cell culture and/or purification, engineering or validation

• Must have knowledge of cGMP, commercial operations and root cause analysis tools

• Initiation and closure of deviations, change controls, CAPAs, investigations to support product/raw material disposition and ensure compliance to regulations and procedures.

• Analyze investigations and ensure: quality of written records; technically sound root cause analysis and product impact assessment; identification of appropriate corrective actions; closure

• Harmonize content expectations and writing styles within the Lexington site via collaboration with peers, QA contacts, PIER and BPO function

• Ensure deviation records are compliant and in a state of inspection readiness at all times

• Prepare SMEs for and present investigations during regulatory inspections and audits

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.

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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Lexington - BIO OPS

U. S. Base Salary Range:

$133,000. 00 - $209,000. 00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualif.