This position is responsible for Massachusetts Biologics Operations (MA Bio Ops) site inspection readiness. The scope of this role includes inspection readiness at the Lexington and Alewife manufacturing facilities as well as their associated satellite warehouse locations, for inspections and audits performed by Health Authorities and business partners.
This position will be responsible for inspection & audit management, as well as the identification, training and resourcing of supporting roles. This position will be accountable for managing the site response to any adverse findings including CAPA completion on time and in full, to deliver on the organization s commitments.
This leadership role will partner closely with other MA Bio Ops management teams and supporting organizations, to ensure finding responses from other Takeda sites as well as external Regulatory Intelligence is assessed for applicability and appropriate action is taken in a risk based fashion.
Regulatory Inspection Process
- Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, as well as the regulations and standards applicable to Massachusetts Biologics Operations (MA Bio Ops).
- Represents Takeda MA Bio Ops during regulatory inspections assuring management that requested information is produced in a timely, accurate and complete manner.
- Assures that inspection / audit responses are timely and appropriate to maintain good standing with regulatory agencies.
- Coaches and educates cross functional Takeda staff in regulatory inspection readiness activities.
- Responsible for maintaining site licenses, renewals and paper inspections including holding department owners accountable for timely completion of requests in support of paper inspections.
Site Risk Register
- Develop and maintain a Risk Register for MA Bio Ops, to include a comprehensive listing of actions to reduce the site s overall risk profile
- Recommend endorsement of Continuous Improvement projects and associated actions based on the severity and frequency of the associated risks to be mitigated
- Ensure finding responses from other Takeda sites as well as external Regulatory Intelligence are assessed for applicability and appropriate action is taken in a risk based manner
Leadership & Partnership
- Provide leadership and guidance to the Takeda MA Bio Ops organization to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable.
- Provides ongoing development of direct reports, including staff selection, work assignments, goal completion, development plan review, and performance management, as applicable
- Establishes strong partnership/relationship with key business stakeholders, including Operations Leadership Teams and Department Managers / Supervisors
- Recognized as a senior strategic CMC Quality resource. Acts as a quality resource with expertise in regulations relating to cGMP, ICH guidelines, and Operational SOPs.
- Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
- Must be able to deal with ambiguity, and make decisions under stressful conditions.
- Strong knowledge of Quality Risk Management principles.
New Product Introduction & Product Launch Activities
- Reviews site-impacting regulatory submission data working with Subject Matter Experts to assure timeliness and accuracy of CMC submission documents
- Collaborate with site Product Launch teams to ensure a detailed transfer of information from development execution into the site s inspection readiness file and risk register as appropriate
- Serve as a Subject Matter Expert on Introduction / Launch initiatives with respect to regulatory compliance matters
Education and Experience Requirements
- Minimum Bachelor s degree in pharmacy, chemistry, biology or a related discipline.
- Minimum of 7 years of experience in Quality or related field in the pharmaceutical industry.
- A minimum of 5 years of management experience.
- Demonstrate the Takeda Leadership Behaviors demonstrating Integrity, Fairness, Honesty & Perseverance
- A thorough understanding of pharmaceutical quality management systems relating to clinical and commercial manufacturing, including current GMPs & GDPs.
- Advanced degree
- Experience interacting and collaborating with cross-functional global teams
- Experience working with external manufacturing partners
- Experience in interacting with health authorities including hosting/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.
- Excellent communication skills including verbal, written and proven ability to influence.
- 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
- Ability to effectively lead in a matrix environment.
Complexity and Problem Solving
- Responsible for proposing and supporting strategy for Heath Authority interactions and working through Takeda MA Bio Ops governance bodies to finalize and execute agreed upon strategies
- Provide input to the Quality Leadership Team to make decisions regarding overall Quality strategy for inspection readiness and priorities.
- Provides input to the Operating Unit team to make informed timely decisions regarding overall OpU strategy for inspection readiness at Takeda s manufacturing sites.
- 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 Quality Compliance at MA Bio Ops
- Key stakeholders include but are not limited to: Biologics Operations 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) & third party customers
Other Job Requirements
- Travel between buildings at MA Bio Ops (Alewife, Lexington, North Reading) is expected to be frequent to support inspection readiness activities across the site.
- Further Domestic and International Travel may be required and is estimated to be <10%.
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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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.