Basic purpose of the job:

The Local CDO Site Quality & Compliance Manager provides strategic leadership, functional expertise and oversight at the Operative Unit (OPU) level, accountable for driving the quality in and the compliance of the planning, preparation and conduct, including monitoring of clinical programs across Clinical Development Operations (CDO).

The Local CDO Site Quality & Compliance Manager, in alignment with leadership, works in collaboration with cross-functional partners to lead the OPU design, coordination and implementation of Quality activities and inspection readiness.

Represents the OPU and contributes to the Global CDO functional quality network initiatives, ensuring that clinical trial activities conducted at investigational sites adhere to global standards, regulatory requirements, and internal procedures, thereby safeguarding data integrity, patient safety, and inspection readiness.

The Local CDO Site Quality & Compliance Manager works in collaboration with Quality Medicine and other cross-functional partners to assist in activities addressing findings related to sponsor inspections and/or internal audits focused on CDO.

Deep understanding of QMS per ICH E6, and applicable local regulations in Japan. Implement BI CDO QMS in collaboration with other relevant functions.

oversight responsibility of NC/CAPA relevant activities within CDO Japan, responsible for consolidating audit & inspection findings and responses, sharing lessons learned within CDO Japan to ensure continuous improvement.

Accountabilities:
Proactively identifies and leads the development and implementation of CDO strategic Quality initiatives and inspection readiness. Performs quality reviews, as assigned, including review of BI processes
Acts as primary point of contact for R/OPU CDO non- compliances for triage to Quality Medicine partners. Leads in strategic decision-making. Tackles complex, cross-organizational problems with innovative solutions and collaborates for resolution

Develops and maintains strong working partnerships with Global CDO Site Quality & Compliance, Quality Medicine and other cross-functional partners in rest of CDO.

Develops and maintains relationships with Legal, and other Med/RA functions. Assures a closely coordinated program of CDO Quality activities based on common goals and objectives
In addition, represents the OPU applying comprehensive local regulatory knowledge to shape the strategic direction of the Global functional quality and compliance network initiatives
Leads in-house inspection readiness activities and participates in sponsor and research site regulatory inspections, as requested

Participates in site non-compliance and critical alert meetings, guiding trial teams in the development of Corrective and Preventive Action (CAPA) Plans.

Champions the CDO CAPA process, ensuring excellence and adherence to quality standards
Responsible for the timely delivery of training/re-training for non- compliances and CAPA resolution and to identify and understand trends in training deficiencies

Contributes to the design, review and reporting of metrics to identify and assess quality trends, individual performance needs and/or compliance issues.

Proactively identifies potential areas of risk and leads collaboration with CDO team members to establish and implement comprehensive risk mitigation strategies, ensuring timely follow-up on all actions.

Leads CDO execution of quality process improvement initiatives, including training programs to address quality and/or performance issues and foster continuous learning and professional development within the team
Ensures trends or lessons learned are disseminated to the OPU CDO organization on a routine cadence
Represent OPU CDO functional quality and compliance on local/global working groups, as requested
Reviews all new global processes for local implementation and liaises with appropriate local functions to ensure smooth rollout in the OPU
Accountable for driving the implementation of innovative process improvements and best practices to optimize team performance and achieve organizational goals
Lead and support CDO teams in day-to-day delivery of tasks by serving as the primary point of contact for process-related questions
Proactively facilitate the transfer of in-depth knowledge of monitoring and trial management skill sets to empower and enhance the effectiveness of the CDO team


Related performance indicators:
Meet project development timelines, performance metrics, and quality and compliance objectives. Monitors resource needs to support Quality activities, including the quality of deliverables
Supports cross-functional activities that support and/or advance the business in compliance with regulations and GCP/ICH both internally and externally
Provides guidance and/or deliverables in adherence to timelines
Adherence to CAPA process throughout CDO
Accuracy & quality data maintained and timely reporting of trends
Identification of processes and programs to ensure delivery of relevant information for functional roles.

Develop opportunities for both coaching and mentoring within and outside of the CDO organization to integrate institutional knowledge cross- functionally.

Create opportunities for greater employee engagement
Support local and global initiatives with SMEs
Demonstrates comprehensive knowledge of Boehringer's mission, business processes, policies and practices

Regulatory and / or Organisational Requirements:

Adherence to national and international regulatory and legal rules and ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI business practices, HTGs and regulatory requirements.

Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality, in accordance with BI values and a focus on speed, innovation, and patient value.

Job Complexity:

The role requires navigating global and local regulations, collaboration with cross- functional teams, ensuring consistent quality and compliance across R/OPU, and balancing the needs of internal stakeholders and external partners to deliver high- quality clinical trials efficiently and ethically.

Interfaces:

Internal:
Clinical Development Operations teams, Quality Medicine, Regulatory Affairs, Medical Affairs, R/OPUs, Clinical Project Managers and study teams, Legal and Compliance departments, training and capability building teams, data management, and biostatistics

External:
Contract Research Organizations (CROs), clinical trial investigators and site staff, health authorities and regulatory agencies, external auditors, vendors and service providers, ethics committees, and Institutional Review Boards (IRBs/ IECs)


Job Expertise:
Extensive experience in clinical trial operations, preferably in a compliance leadership role
Deep understanding of ICH-GCP, IRB/IEC processes, and global regulatory frameworks
Experience in site-level monitoring, inspection readiness, and risk-based quality management
Ability to lead cross-functional teams and influence without authority
Strong analytical, communication, and project management skills


Minimum Education/Degree Requirements:
Master's or comparable degree or high-quality/multiple-faceted professional qualifications with work experience relevant to the job.


Required Capabilities (Skills, Experience, Competencies):

Working knowledge of ICH GCP and applicable regulations (Minimum of 6+ years of relevant business experience in the regulated pharmaceutical or healthcare industry).

Prior clinical trial experience required (CRA, study manager, prior quality roles).

Knowledge of the different functions involved in the planning, conduct and monitoring of clinical trials for all phases of trials.

Working knowledge of clinical research principles and process.
Prior experience with preparation for or participation in regulatory authority inspections a plus; not mandatory.
Ability to work independently and as part of a team.
Exercise sound judgment in planning and accomplishing goals.
Strong oral and written communication skills.
Strong organizational and planning skills with effective time management.
Strong interpersonal skills.
Strong attention to details.
Ability to work under pressure and deal with time demands.
Ability to exercise critical thinking skills, proactively identify issues, and address with a solution-oriented approach.
Ability to provide input into process initiatives, SOPs related to the conduct of clinical trials.
Ability to travel overnight domestically and/or internationally, as needed.
Ability to use and learn system applications, e.g., MS Office, Access, Outlook, document management systems, etc.

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority.

Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare.

By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-

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