Product Quality Complaints Manager

Sumitomo Pharma Co. Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America Inc.) focused on addressing patient needs in oncology urology womens health rare diseases cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets we aim to accelerate discovery research and development to bring novel therapies to patients sooner. For more information on SMPA visit our website or follow us on LinkedIn.

Job Overview:

This position reports to the Senior Director PV Quality Assurance and is part of the Quality department which is responsible for ensuring compliant management of product complaints associated with commercial and clinical products. The role is responsible for the intake assessment investigation documentation and closure of product complaints in accordance with applicable regulatory requirements and company procedures and works closely with Pharmacovigilance Manufacturing Quality Assurance and external partners to support product quality patient safety and regulatory compliance.

Essential Functions Required for Job

• Manage the intake assessment documentation investigation and closure of product complaints for commercial and clinical products in accordance with applicable regulations and company procedures
• Receive evaluate and process product complaints including identification and forwarding of potential adverse event lack-of-effect and product quality reports to appropriate functions.
• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments.
• Ensure complaint records are complete accurate well-written fact-based and maintained in a state of inspection readiness.
• Manage follow-up activities with consumers healthcare professionals pharmacies distributors and other external contacts as necessary to obtain complaint information and supporting documentation.
• Coordinate product sample return activities sample tracking laboratory testing requests and related complaint documentation.
• Draft and issue complaint response communications as required.
• Maintain compliance with cGMP requirements regulatory expectations and internal quality procedures.
• Review and approve product complaint records investigations assessments customer communications and closure documentation to ensure completeness accuracy compliance and adherence to company procedures.
• Exercise independent judgment in evaluating complaint information determining investigation requirements assessing product quality impact and recommending appropriate disposition and closure activities.

Knowledge Skills and Abilities (general & technical):

• Strong knowledge of FDA global GMP pharmacovigilance and product complaint regulations and guidance.
• Demonstrated experience managing pharmaceutical biotechnology medical device and/or combination-product complaint processes.
• Excellent investigation root cause analysis problem-solving and risk assessment skills.
• Experience utilizing electronic quality management systems (eQMS) and complaint management databases.
• Strong written and verbal communication skills with the ability to communicate effectively across all levels of the organization.
• Ability to effectively prioritize multiple competing activities in a fast-paced highly regulated environment.
• Strong attention to detail and commitment to data integrity and documentation quality.

Education & Experience Requirements:

• Bachelors degree in a related field required.
• Solid experience with product complaints investigations quality systems and regulatory compliance activities required.
• Working knowledge of cGMP requirements and quality management systems required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry Bachelors Degree or equivalent years of work experience.
• Minimum 3 years of product complaint experience required.

Other Requirements (licenses certifications specialized training and physical or mental abilities required):

• Comprehensive understanding of cGMP requirements and pharmaceutical quality systems.
• Ability to maintain confidentiality and handle sensitive product quality and patient information.
• Ability to work independently and make sound risk-based decisions using independent judgment.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

This is an individual contributor role and does not have direct reports or formal peoplemanagement responsibilities.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases short incentive plan participation eligibility for our 401(k) plan medical dental vision life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off 11 paid holidays plus additional time off for a shut-down period during the last week of December 80 hours of paid sick time upon hire and each year thereafter. Total compensation including base salary to be offered will depend on elements unique to each candidate including candidate experience skills education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

Confidential Data: All information (written verbal electronic etc.) that an employee encounters is considered confidential in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the best industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements
Applicants for sales/field manufacturing or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital domestic partnership or civil union status; sex gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please contact SMPA at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Required Experience:

Manager