QUALITY EXTERNAL ENGAGEMENT (SR DIRECTOR)

Job Description About the role.
About the role.
The Senior Director Quality Compliance and Systems is responsible for ensuring the quality of processes and product outputs.
This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards.
By maintaining high-quality standards, this role supports Takeda's commitment to delivering exceptional products and services.
How you will contribute.
* Define and specify activities, processes, and standards to fulfill quality requirements * Audit, monitor, and determine the quality of processes or outputs against defined standards * Conduct product integrity testing and ensure compliance with quality requirements * Report on process deviations and defects * Oversee multiple teams led by Senior Managers and Managers * Shape corporate policies and provide guidance to directors and senior managers * Interact with executive leadership on significant organizational matters Skills and qualifications.
* Can independently execute validation protocols in routine and moderately complex situations, demonstrating a comprehensive understanding of testing strategies and quality benchmarks.
* Applies Good Manufacturing Practices independently in routine and moderately complex situations with minimal guidance.
* Able to independently execute qualification protocols for installation, operational, and performance qualification in routine scenarios.
* Performs cleaning validation independently, ensuring machinery is contaminant-free.
* Manages change control procedures for routine and moderately complex changes effectively.
* Implements Corrective And Preventive Action strategies independently, identifying flaws and formulating preventive measures.
* Conducts risk analysis independently, applying standard and some advanced strategies for mitigation.
* Manages projects independently, employing a comprehensive understanding of project management principles.
* Conducts audits independently in routine and moderately complex situations, with a comprehensive understanding of auditing principles.
* Drafts and adheres to a Validation Master Plan for routine and moderately complex processes.
* Applies regulatory compliance independently in routine and moderately complex situations.
* Applies Continuous Improvement Process principles independently, showing a comprehensive understanding of the concepts and methodologies.
As a strategic leader overseeing multiple functional areas, divisions, or product groups through directors and managers, with global or multi-country-level responsibility.
You will shape corporate policies, provide guidance to directors and senior managers, and hold a recognized influential position.
Your decisions impact the success of the division, group, company, or corporation, and you may sit on a leadership team, directly influencing the overall business strategy of your area.
To define and implement an external engagement strategy, governance and associated capabilities to ensure that Takeda is recognized by GxP regulatory authorities and industry peers as a thought leader in the areas of innovation, science/technology, quality and compliance.
Engages with key quality pharmaceutical and life sciences industry associations to represent the company on quality and compliance strategic topics.
Design and implement governance processes and cross-divisional/cross-functional governance bodies that support the nomination and participation of internal leaders and subject matter experts in Industry Associations and joint Regulatory/Industry initiatives.
Ensure early identification and assessment of emerging topics/expectations in the quality GxP compliance/regulatory space to define the company´s strategy and involvement, in close collaboration with Quality Systems regulatory intelligence group.
Collaborates with Global Quality Communications, to ensure timely approval from GQ Communications on all external facing presentations and any accompanying resources, according to corporate guidelines.
Uses strong interpersonal, persuasive, problem solving and communication skills to facilitate the definition of the program scope, goals and results for all external engagement programs and activities, working closely with GQ Communications.
How you will contribute.
Assess the landscape of major GxP and Life sciences industry associations and joint regulator/industry initiatives to decide where the company must be represented and why, including impact expected.
Contributes  to Takeda’s external reputation within the Quality and Compliance space, in alignment with GQ Communications.
Builds connections and externally liaise to promote Takeda as an industry leader in quality compliance best practices and innovation.
Manages key relationships and strategies with key quality pharmaceutical and life sciences external groups, trade associations.
Responsible for building trust and leading strategic relationships with key industry stakeholders.
Ensure that an internal Takeda network of subject matter experts exists and supports the internal key opinion leaders in their external engagement activities.
Designs and implements internal processes and communication mechanisms to assess emerging quality and compliance regulatory expectations for their impact on the company.
Proactively escalates how emerging regulatory trends and expectations could impact Takeda’s enterprise QMS.
Establishes global governance, provides oversight and support to all Quality related external engagement activities including among others.
External Speaking events, i.
.
Professional Conferences (keynote speaker, presenters, interest groups, panellists), industry organizations committees, forums; Participation on industry technical reports, guidance review and feedback; Review and approve all materials referencing Quality Management Systems within Takeda to ensure alignment with all internal global standards and procedures.
Coordinate additional review and approval of relevant internal SME’s of these materials.
Ensure materials have complied with global communications and legal processes prior to any external use.
Leads and/or supports as required any internal global quality engagement activities such as Quality Summit, Quality Week, Quality Culture or any other global quality engagement activity geared towards quality improvement and innovation.
Ensures proper mechanism is in place to share in a timely fashion any lessons learned from external engagement activities across the Quality enterprise.
Develops and manages external engagement SharePoint site as central repository and point of reference for all Quality external engagement initiatives, calendar of activities, links, reference materials, etc.
Dimension and Aspects Technical/Functional (Line) Expertise Extensive knowledge and experience of Bio-pharmaceutical Research, Development and Manufacturing  Knowledge and understanding of relevant emerging regulations and related processes Knowledge of diverse therapeutic areas and recent innovative treatments Knowledge of SharePoint capabilities.
Leadership Achieve the vision to be recognized by Regulatory Authorities as a thought leader in the Industry in the areas of innovation, science and technology, quality and regulatory compliance, and continuous improvement.
Strategic role to prepare the internal organization for emerging regulatory expectations in GxP areas, across the lifecycle of biopharmaceutical products at Takeda.
High visibility of the incumbent representing the company in major industry initiatives and in interactions with regulators, as well as internal visibility with executive leadership.
Decision-making and Autonomy A member of Global Quality Compliance and Systems team Ad-hoc participation with GQLT as needed Responsible for internal processes and systems to support external representation are implemented and effectively working.
Full budget accountability for designated area Interaction Benchmarking results and emerging expectations from external activities are communicated effectively across internal divisions/functions and used to drive action and continuously improve internal products, submissions and quality and scientific processes and systems.
Through the incumbent’s contributions with regulators and industry peers, the reputation of the company is continuously enhanced.
The company is involved in strategic initiative with regulators and considered a “go to” organization for benchmarking by peer companies and regulators.
External engagement succession planning process is in place to ensure continuous representation in major Industry Associations/Regulatory forums on the strategy and policy setting level as well as for technical topics.
Innovation A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry Complexity An external engagement strategy is defined and implemented (aligned with Takeda business imperatives) to ensure that the company is represented across the GxP areas of the product lifestyle in major Industry Associations/Regulatory forums at both the strategy/policy setting level as well as for technical topics, to achieve the overall vision to be recognized as a thought leader in the external environment.
What you bring to Takeda.
Bachelor degree in Life Sciences, Pharmacy or Medicines, or related discipline, advanced Degree or PhD a plus Languages.
Fluent in English (oral and written); additional languages desirable    Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Quality.
Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.
.
US FDA, EU, PMDA, WHO).
Actively engaged in major industry associations (e.
.
EFPIA, PhRMA, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.
.
ICH).
Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
High organization awareness (e.
.
interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.
More about us.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
Empowering our people to shine.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career.
We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location.
Lexington, MA U.
.
Base Salary Range.
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.
.
based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
U.
.
based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.
.
based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.