Otsuka Pharmaceuticals

Manager, Design Quality

Otsuka Pharmaceuticals$130K — $216K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Quality Management, or related field.
  • 7+ years of experience in quality management and product design within consumer healthcare, pharmaceuticals, or nutraceuticals.
  • Proven experience leading quality initiatives in product development and commercialization.
  • Strong understanding of risk management principles and regulatory requirements.
  • Exceptional communication and stakeholder management abilities.
  • Competence in influencing without direct authority within cross-functional teams.
  • Experience using consumer insights to inform product development.

Responsibilities

  • Own and implement Pharmavite's quality standards in all product design phases.
  • Conduct risk assessments with technical leaders and develop mitigation strategies.
  • Recommend best practices for quality risk processes during design and commercialization.
  • Collaborate with cross-functional teams to ensure new products are manufacturable.
  • Communicate risks and recommendations to stakeholders effectively.
  • Drive improvements based on consumer feedback and quality metrics.
  • Maintain quality processes to support innovation and product launches.

Benefits

  • Annual performance bonus
  • Medical, dental, and vision benefits
  • 401K match
  • Wellness benefits
  • Total rewards package offering beyond base pay
Full Job Description
This role is not available for any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT.

Position Summary:

The Design Quality Manager plays a critical role in ensuring that Pharmavite's products meet the highest standards of quality throughout the design, development, and launch phases. Reporting to the Director of Design Quality, this position is responsible for executing quality strategies, managing risk assessments, and providing quality leadership and risk-based recommendations to cross-functional teams to deliver consumer-centric, compliant, and manufacturable products. The Manager will also drive continuous improvement initiatives and foster a culture of quality within the organization.

Critical Success Factors:

  • Ability to manage ambiguity and complexity with a strong risk management mindset. Can proactively identify, assess, and mitigate quality risks throughout product development to ensure successful commercialization and consumer safety.
  • The ability to influence and collaborate across functions, building strong partnerships with R&D, Marketing, Regulatory, Operations, and Supply Chain to drive quality-focused decisions.
  • A passion for consumer advocacy, consistently incorporating the voice of the consumer into product design and using feedback and quality data to improve consumer experiences.
  • Experience supporting product development and commercialization, with an understanding of how to balance innovation, manufacturability, compliance, and quality throughout the product lifecycle.
  • A solid foundation in quality systems and regulatory requirements, enabling you to ensure products and processes meet internal standards as well as industry and regulatory expectations.
  • Strong analytical and data-driven decision-making skills, with the ability to translate quality metrics, risk assessments, and consumer insights into actionable recommendations.
  • Excellent communication skills which foster the ability to lead through influence, living a culture of quality, accountability, and continuous improvement while guiding teams toward sound, risk-based decisions without direct authority.


Key Responsibilities:

Design Quality Execution

  • Ownership of Initiatives that implement Pharmavite's quality standards and consumer-focused quality perspective in all phases of product design and development.
  • Partners with technical leaders to conduct risk assessments for products and projects, identify potential issues, and support the development of mitigation strategies.
  • Develop recommendations to ensure optimal enterprise approach of quality risk processes during design, innovation, and commercialization, ensuring compliance with internal and external standards. Be a key advocate of best practices across the project portfolio, business processes, and product development through the product lifecycle.
  • Collaborate with R&D, Marketing, Operations, and Regulatory Affairs to ensure new products are manufacturable and feasible.
  • Communicate project and product risks to the Director of Design Quality and other stakeholders, providing recommendations for mitigation.
  • Support ongoing product portfolio maintenance by evaluating quality performance and driving improvements based on consumer feedback and quality data.
  • Develop and maintain quality processes and systems to support innovation and product launches.
  • Promote a culture of quality and consumer advocacy within project teams.
  • Ensure adherence to regulatory requirements and industry standards throughout the design and development process.
  • Prepare and present risk assessments, quality reviews, and project status updates to the Director of Design Quality.
  • Support the Supplier Quality and Verification Program teams, to ensure Design Quality requirements are being integrated and supported across the group.


Qualifications:

  • Bachelor's degree in Science, Quality Management, or a related discipline.
  • Minimum of 7 years of experience in quality management, product design, or a related field within consumer healthcare, pharmaceuticals, or nutraceuticals.
  • Experience in leading quality initiatives in product development and commercialization.
  • Knowledge of risk management principles, quality systems, and regulatory requirements.
  • Strong communication and stakeholder management skills.
  • Manage by influence rather than authority. Ability to work effectively in cross-functional teams and support quality-focused decision-making.
  • Experience with consumer insights and integrating the voice of the customer into product development is a plus.
  • Conceptual thinker capable of creating and communicating a framework and organizational structure during design quality. Analytical mindset with the ability to assess project risks and develop actionable solutions.


Reporting Structure

  • The Manager, Design Quality reports directly to the Director of Design Quality and works closely with cross-functional teams across Pharmavite.


Work Environment

  • This position is based at Pharmavite's headquarters and may require occasional travel to manufacturing sites and suppliers.


National Target Base Pay Range: $117,000.00 - $195,000.00

The salary range for this position is based on national standards. For candidates in California and the New York metro, the Target Base Pay Range is $130,000.00 - $216,000.00, to reflect the cost of living and market conditions in those areas.

Actual compensation will take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location, education, experience, qualifications, and job-related skills. It is not typical for an individual to be hired above the midpoint of the range for their role, and compensation decisions depend on the facts and circumstances of each case. This information is provided to applicants in accordance with state and local laws.

Base pay is only one component of our total rewards offerings, and we will take the full offering into consideration when presenting an offer of employment. Our total rewards package for this position may also include an annual performance bonus, Medical, dental, and vision benefits, 401K match, and other wellness benefits.

About Otsuka Pharmaceuticals

Otsuka Pharmaceutical is a Japanese pharmaceutical company that develops and markets a range of products including prescription drugs, over-the-counter medications, and nutritional supplements. The company was founded in 1964 and is headquartered in Tokyo, Japan. Otsuka Pharmaceutical has a strong research and development program and has developed several innovative drugs for the treatment of various diseases. The company is committed to sustainability and has implemented several initiatives to reduce its environmental impact. Otsuka Pharmaceutical has a global presence and operates in several countries around the world.
Learn more about Otsuka Pharmaceuticals
Size
9,171 employees
Industry
Founded
1989
NASDAQ

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