Executive Director, R&D Global Quality

Otsuka America Pharmaceutical Inc.; Hagåtña (GU); A distancia; USD 250.000 - 388.000; Jornada completa

Descripción de la vacante

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team across US, Asia, Europe and North America.

This role ensures inspection readiness, oversees clinical trial and submission support, and drives the R&D audit program and data integrity across affiliates. The leader will set strategic direction for Global Quality, including GCQ, CSV and GPV, partner with business groups to harmonize processes, and identify quality risks from development

Formación

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials.
• Experience with audits and regulatory inspections.
• Experience with Japanese company or multinational with Japanese arm.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• Travel approximately 30%.

Responsabilidades

• Inspire and develop a team of Quality professionals and deliver the Global Quality strategy.
• Ensure internal and external sites are inspection ready and CAPAs are implemented.
• Lead clinical facility and system audits and ensure corrective actions are documented.
• Establish standards and procedures to ensure quality and compliance across business units.

Educación

Bachelor’s degree in a relevant field

Descripción del empleo

Remote

Full time

R12983

Job Summary

We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity.

The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution.

Job Description

• This critical leader will inspire and develop a team of Quality professionals, partner closely with key stakeholders, and assist in the development and delivery of the overall Global Quality (GQ) strategy.
• This position is responsible for ensuring internal and external sites are inspection ready, resources are provided on site and/or remotely during health authority inspections, observational findings are responded to appropriately and within the required timeframe, and resultant CAPAs are implemented and checked for effectiveness to prevent recurrence. A key deliverable of this role will be analysis of findings and holistic assessment of how the organization can address systemic trends to operate more efficiently and effectively.
• This role will take a leadership position in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and appropriate corrective actions are implemented and documented on a timely basis.
• In addition, this role is responsible for establishing standards and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting non-compliance and mitigating risks, The performance of the Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company policy and strategy and gain a consensus of risk mitigation approaches.

Key Responsibilities

• Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
• Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements.
• Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings.
• Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
• Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
• Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements.
• Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance.
• Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight.
• Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.
• Budget Management: Develop and manage the departmental budgets.

Qualifications/ Required

Knowledge/ Experience and Skills:

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. Current and in-depth knowledge of audit techniques and government regulatory inspection procedures
• Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi-national with a Japanese arm.
• Previous experience of working in the global pharmaceutical and medical device industry.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Exceptional leadership and team development skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Strategic thinking and problem-solving abilities.
• Travel (approximately 30%)

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail] .

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond - under any circumstances, for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company has earned us certification as a Great Place to Work by the Great Place to Work Institute.