Quality Assurance Value Stream Manager

Takeda Pharmaceutical Company Ltd Lexington , MA 02421

Posted 2 months ago

Primary Duties

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.

Responsibilities:

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

Essential

  • Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following values:

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

  • 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

Helpful

  • Previous management experience will be helpful but is not required. Demonstration of leadership behaviors is important to succeed in this role.

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:

  • Quality Control
  • Mass Bio Ops and above site groups (ie. External Quality, Stability)
  • External (Global) QA groups

  • Manufacturing

  • Facilities & Engineering

  • Materials Management

  • 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

  • Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manufacturing Quality Engineer I (533093)

T2 Biosystems

Posted 2 months ago

VIEW JOBS 10/14/2020 12:00:00 AM 2021-01-12T00:00 We are seeking an energetic, process-driven, and detail-oriented individual to join our team as a Manufacturing Quality Engineer I. This is an exciting role that will support our instrument manufacturing operations and is responsible for promoting product quality and continuous process improvement. The position reports directly to the Senior Director, Instrument Manufacturing, Supply Chain and Facilities. The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results. S/he will lead by example with a positive, can-do attitude and will apply their critical thinking skills when getting things done. This individual must be able to communicate with team members at all levels and be comfortable both challenging and influencing others and being challenged by others without getting defensive. In addition to those skills and attributes, we're looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization. Responsibilities: * Work with Manufacturing to determine appropriate quality metrics for all manufacturing processes and report on them as appropriate. * Participate in the process of developing, implementing and monitoring detailed guidelines on what needs to be checked and what the quality standards in the Manufacturing process are. * Drive regular review of Manufacturing process to identify opportunities for improvement. * Participate in the inspection of finished products, in process assemblies and raw materials. * Work with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions. * Assist in driving timely completion of Non-Conformances while preventing repeat occurrences. * Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to address product design and manufacturing issues. * Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics. * Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify effectiveness. * Support process and product-related deviation activities including tracking and trending. * Support complaint investigation, recordkeeping and trend reporting. * Maintain positive and effective communication and collaboration with all levels of the team and our outside partners and vendors. * Other tasks as needed to support organizational goals and objectives. Skills and Experience: * Bachelor's Degree in engineering related discipline required. * Minimum of 5 years of relevant Quality Management experience in an FDA regulated environment required, ideally within medical device, in vitro diagnostics or pharma industry. * ASQ or Six Sigma Certification or equivalent is desired. * Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required. * Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred. * Must be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations. * Experience working with Quality Systems compliant with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820. * Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associate with these drawings. * Must be familiar with relevant inspection techniques and equipment. * Must have strong technical writing, statistical sampling and data analysis skills; proficient with Microsoft Excel. * Must demonstrate sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail. T2 Biosystems Lexington MA

Quality Assurance Value Stream Manager

Takeda Pharmaceutical Company Ltd