The QA Value Stream Manager (VSM) is an experience Quality Assurance professional who will lead the QA Operations function in supporting key programs at MA Bio Ops, including New Product Introduction and Technical Transfer projects, program risk assessments, and continuous improvement activities. In this role, the individual will represent QA Operations on project teams, providing direction and ensuring a compliant, Quality mindset.
As a partner for New Product Introduction and Technical Transfer activities, the position will work with project teams to ensure phase appropriate controls are implemented for the manufacturing, testing and disposition of clinical phase drug substance, in accordance with global standards.
Additionally, this role provides Quality support for regulatory filing activities, inspection preparedness, and incident escalation above site.
Daily activities will include, but not be limited to the following:
Participate in new product, tech transfer, and project meetings, representing QA Operations for the site.
Perform gap assessments, risk assessments, and site risk review activities.
Provide QA Floor and QA Technical/Dispo teams with support as needed by performing review and approval of Quality Systems such as deviations and/or change controls and calibration system records.
Attend visual management boards as agreed on by QA team.
Uphold data integrity and GxP standards across the Quality and Manufacturing organization.
Close partnership with other groups responsible for Documentation, Validation, Technical Services, Investigations, Project Management, Reliability, Facilities & Maintenance, Scheduling, and Tech Transfer.
Support Inspection-related activities, including gap assessments, risk assessments, remediation activities within sphere of influence. Also direct support of site inspections through SMEs as well as personnel for logistics of the inspection.
Report on agreed upon metrics and attend Visual Tier boards as appropriate.
Drive a continuous improvement mindset within the QA Operations team by purposeful critical assessment of QA processes and improvement identification; support CI activities within the larger Mass Bio Ops site.
Demonstrate key Shingo principles through respect for individuals and focus on process, and Gemba walks.
Adhere to Takeda Values and apply to decision making and activities.
Education and Experience Requirements
Requires a minimum of a bachelor's degree in a related discipline such as science, engineering or other technical field.
6-8 yrs minimum experience in a biotech and/or pharmaceutical GMP setting, preferably associated with Quality operations or compliance.
Experience executing, developing, and/or administrating GMP quality programs.
Participation or leadership in lean/six sigma continuous improvement activities, or similar.
Key Skills, Abilities, and Competencies
Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following values:
Thorough knowledge and adherence to applicable procedures, specifications, regulations and standards. Awareness of regulatory requirements and guidelines for US and Europe.
Ability to navigate technical discussions and apply problem-solving skills.
Ability to support risk-based decisions with logic that balances business and compliance needs
Ability to collaborate with and influence on a diverse team of employees.
Strong communication and interpersonal skills.
Good time management skills.
Self-starter and meets comitments.
Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint; ability to learn additional software applications, as the need arises.
Flexibility, adaptability, open to change.
Embrace feedback process, both giving and receiving
Complexity and Problem Solving
Employee at this level is involved in a variety of tasks of moderate to high level scope and complexity.
Candidate receives general instructions on new work; refers to policies and practices for guidance.
Work is reviewed for technical soundness and accuracy only where needed.
Responsible for implementing QA approaches based on sound principles, international industry/regulatory standards, and robust scientific basis.
Responsible for troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.
Internal and External Contacts
In addition to routine interaction within QA management, key collaborations for this position involve management from the following departments:
External (Global) QA groups
Facilities & Engineering
North Reading and Alewife Brook Parkway value streams
External contacts include regulatory agency personnel and guests on an ad hoc basis.
Other Job Requirements
This position is Monday through Friday, first shift. However, flexibility may be needed to cover off-hours project work during 2nd or 3rd shift, or occasional weekend support.
Travel only on ad hoc basis.
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law
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.
Takeda Pharmaceutical Company Ltd