- Entry level
- No Education
- Salary to negotiate
- null US
This position is responsible for oversight and proper execution of the Quality Control testing associated with Cell Therapy products at the Massachusetts Biologics Operations (MA Bio Ops) Lexington site. This includes but is not limited to scheduling testing according to both cGMP requirements and supply chain needs, ensuring tests are executed in accordance with well written procedures and method validation, a robust training is established and completed, and test performance and results are promptly reviewed. Furthermore, this position will entail as necessary aspects of analytical method troubleshooting, performing investigations into Out-of-Specification or Out-of-Trend results, as well as conducting investigations into any testing discrepancies.
As part of the role, this individual will be responsible for ensuring the department budget is respected - coordinating with peers as needed to make any budgetary corrections or adjustments.
The incumbent will also be responsible for defending the QC Cell Therapy programs and decisions to Regulatory Agencies and Site / Corporate senior leadership as necessary.
This role will partner closely with other individuals and teams across the site in fulfillment of both department as well as site objectives. This includes routine collaboration with leadership counterparts across other areas within QC, Quality Assurance, Supply Chain Management, and most importantly, the operations units the department supports. As needed, this individual will also interface with members from Regulatory Affairs, Human Resources, as well as other key support functions across the site organization.
As this is a leadership position with direct reports, a core function of the role pertains to the effective development of emplpyees including various aspects related to leadership and management responsibilities.
Quality Control Testing Process
- Ensures that testing is performed as scheduled in accordance with site, corporate, and regulatory requirements.
- Responsible for assay life-cycle management of QC methods within the assigned Cell Therapy Quality Control platform to provide robust methodologies for product testing
- Responsible for ensuring compliance with all applicable (Quality Control - related) provisions of the Takeda Quality Management System, as well as the regulations and standards applicable to the Massachusetts Biologics Operations (MA Bio Ops) Quality Control Laboratory.
- Represents Takeda MA Bio Ops Quality Control during regulatory inspections, ensuring that requested information is produced in a timely, accurate and complete manner.
- Assures that associated inspection / audit responses are timely and appropriate to maintain good standing with regulatory agencies.
New Product Introduction & Product Launch Activities
- Serve as a Quality Control Subject Matter Expert on Cell Therapy product Introduction / Launch initiatives.
Leadership & Site Integration
- Provide leadership and guidance in the Quality Control organization to ensure the development and implementation of strategies regarding the QC processes, procedures and quality standards required are maintained in compliance with applicable regulations.
- Establishes strong partnership/relationship with key business stakeholders, including Operations Leadership Teams and Department Managers / Supervisors
- Recognized as a senior strategic Quality Control resource.
- Acts as a quality resource with expertise in regulations relating to site, corporate, and regulatory requirements.
- As a people manager, it is the expectation that this individual is actively engaged in the development of their staff including managing performance, building and executing effective succession planning, staff recruitment / on-boarding, as well as motivating teams.
Education and Experience Requirements
- Minimum Bachelor's degree in a related discipline.
- Minimum of 7 years of experience in Quality Control or related field in the pharmaceutical industry.
- A minimum of 3 years of management experience with direct reports.
- Demonstrate the Takeda Leadership Behaviors demonstrating Integrity, Fairness, Honesty & Perseverance
- A thorough understanding of requirements / regulations related to Quality Control in a cGMP environment.
- Strong knowledge of biological or cell culture based QC methods including flow cytometry and PCR (polymerase chain reaction)
- Experience interacting and collaborating with cross-functional global team
- Experience with method validation and technology transfer preferred
- Advanced degree in a scientific or engineering discipline
- Experience working with biological or cell culture based QC methods
- Experience working with external manufacturing partners
- Experience in interacting with health authorities including direct involvement with agency inspections.
Key Skills, Abilities, and Competencies
- Proven ability to create a vision and motivate others to achieve that vision.
- Ability to make difficult, robust, rationalized and timely decisions balancing the totality of available data and risk.
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, enable trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
- Adopt and exemplify the Takeda Values throughout the Organization: Integrity, Fairness, Honesty & Perseverance
- Excellent communication skills including verbal, written and proven ability to influence, lead, and motivate teams.
- Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence as well as trust of stakeholders.
- Ability to interact effectively with Health Authorities and various Takeda stakeholders
Complexity and Problem Solving
- Responsible for proposing and supporting strategy QC test scheduling and execute agreed upon strategies.
- Provide leadership and effective decision making in the event of unplanned test issues (for example, Out-of-Specification results).
- Provides input to the Biologics Operating Unit team to make informed timely decisions regarding overall QC test method performance.
- Monitors established goals and projects and takes action as needed to ensure timely delivery of goals.
Internal and External Contacts
- The role is accountable directly to the Head of MA Bio Ops Site Quality Head
- Key stakeholders include but are not limited to: Biologics Operations Unit Quality, MA Bio Ops Site Quality, Site Operations Leadership Teams, Manufacturing, Technical Services, Facilities & Engineering, External Quality, Quality Supply and Distribution, Supply Chain, Quality Control, Operational Excellence, IT, Pharmacovigilance, Regulatory Affairs.
- External: Competent Health Authorities (i.e. FDA, PMDA, HPRA, MHRA, TGA, ANVISA, Cofepris).
Other Job Requirements
- Travel between buildings at MA Bio Ops Lexington site is expected to be frequent to support interaction with peers across the site.
- Further Domestic and International Travel is expected to be minimal
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
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