Associate Director - Quality Regulatory Compliance

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Job ID SR*******

Date posted 10/18/2019

Location Lexington, Massachusetts; Cambridge, Massachusetts; North Reading, Massachusetts

Primary Duties

This position is responsible for Massachusetts Biologics Operations (MA Bio Ops) site inspection management and oversight of regulatory compliance programs. 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 oversight of the inspection & audit management process, including 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 organizations 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.

Other aspects of the Quality Compliance area this role will take part in include partnering with Regulatory Affairs on reviews of submission dossiers, as well as researching and disseminating pertinent Regulatory Intelligence to the site.


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.

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 sites inspection readiness file and risk register as appropriate

Serve as a Subject Matter Expert on Introduction / Launch initiatives with respect to regulatory compliance matters

Site Risk Register

Maintain a Risk Register for MA Bio Ops, to include a comprehensive listing of actions to reduce the sites 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 & Site Integration

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

Ensure site Integration activities in areas of responsibility are well understood by the organization and executed in a timely and compliant fashion

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 Quality Compliance 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

Education and Experience Requirements


- Minimum Bachelors degree in a related discipline.

- Minimum of 8 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 in a scientific or engineering discipline

- 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 Biologics Operating Unit team to make informed timely decisions regarding overall OpU strategy for inspection readiness at Takedas 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
  • 1
  • Negotiable
  • None
  • None
  • Re-193780
  • Permanent
  • 0

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