Posted to MedZilla on 10/14/2019

Takeda Pharmaceuticals

US-MA, Quality Compliance Manager SR0041195-MZ


Primary Duties

This position will report into the Associate Director of Quality responsible for the oversight and management of Quality Compliance at the site. This individual will be responsible for managing portions of the quality system program development, implementation, continuous improvement and/or harmonization at the Massachusetts Biologics Operations (MABioOps) Manufacturing Site. Use of project management collaboration skills is essential for program success.


The individual in this position will be a high level contributing member of the Quality Compliance Team and will execute responsibilities with minimal management oversight. This individual will work to ensure the health of the Quality Management System at the site is maintained. Ensures that all facets of the QMS are established and executed on Site within the area of responsibilities. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance. Escalation mechanisms as defined in Site Regulations are being adhered to.

This role works to build, enhance, harmonize and manage quality compliance at the site and is responsible for finding solutions and coordinating changes associated with the solutions.

This role will have responsibilities in some of the following areas:

  • Execution of APQR and related activities
  • Manage/perform execution lead responsibilities for the site as appropriate
  • Provide Quality System guidance and troubleshooting to the site, as needed.
  • Partner with management and other functional areas to project manage more complex and technical issues at the MA Bio Ops Site.
  • Participate in and lead Quality Management Review and related activities
  • Partner with Quality management to proactively address and resolve more complex and technical projects at MA Bio Ops.
  • Represent MA Bio Ops in QMS Integration Activities
  • Quality KPI Reporting and Continuous Improvement
  • Coach and mentor individuals within the Quality department to ensure continued quality and compliance mindset.
  • Represent Quality Compliance during internal audits and regulatory agency inspections
  • Manages ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas and staff in the successful performance of these activities.
  • Drives continuous improvement and Lean Culture
Education & Experience Requirements

Essential: A minimum of a B.S. degree in science or engineering with at least 8+ years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. Prior supervisory experience desired. Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis. Excellent interpersonal skills and the ability to communicate well orally and in writing.

Desired: Direct Biologic Pharmaceuticals experience

Key Skills, Abilities & Competencies

  • Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US, Europe and key rest of world markets.
  • Ability to create, manage and improve Quality Compliance, integrating with existing Risk Mangment practices and expanding upon them
  • Ability to work independently and effectively in a fast-paced environment
  • Strong written and oral communication skills required
  • Ability to lead more complex projects and drive to long-lasting solutions.
  • Good interpersonal skills and ability to effectively work in a team.
  • Adherence to domestic and international GMP regulations, company policies and
  • Strong organizational skills
  • Ability to multi-task in a dynamic environment with changing priorities
  • Strong work ethic
  • Strong prioritization skills
  • Ability to think strategically and tactically, balancing changes to workload.
  • Ability to meet challenging timelines and manage through obstacles utilizing the skills listed above.
  • Self-motivated and driven to independently accomplish department goals and objectives
  • Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus.
  • Must be capable of defining, implementing, and successfully defending sound QA compliance approaches and principles.
  • Demonstrate unwavering ethics and respect for all customers. Practice open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change. When faced with challenging circumstances, finds creative ways to ensure achievement of the desired outcome. Plans, organizes and communicates with others who may have concurrent work streams. Proactively improves customer service. Demonstrate genuine respect for others. Seeks greater understanding of self and others: seeks feedback about one s own behavior Demonstrates leadership qualities. Works effectively in situations that are outside one s usual activities and responsibilities. Fosters employee ownership and development by allowing others to make independent decisions and judgments.
  • Seeks the input of others before making a decision. Demonstrates personal dedication; balances personal needs with Takeda s needs. Illustrates dedication to Takeda by going above and beyond expected individual responsibilities.
  • Leadership Behaviors
    • Be Positive
    • Be Accountable
    • Be Results Oriented
    • Be An Excellent Manager of Self and Others

Complexity & Problem Solving

  • Ability to assess a problem, gain an understanding of the requirements and deliver information back to customers (site and center led functions) as needed
  • Deliver information and decisions back to the site regarding strategy, programs or related information

Monitors goals and projects and takes action as needed to ensure timely delivery of goals.

Internal & External Contacts

Contacts are primarily with other professionals within Takeda

Other Job Requirements

Travel between sites at MA Bio Ops sites is frequently required. Weekend or off-hours activity may be required to support business needs.

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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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.

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