Senior Associate, GPQ Investigator

The Senior Associate PQC Investigator, Global Product Quality – Global GMP Processes and Devices supports Product Quality Complaint activities by coordinating complaint intake, conducting investigations, documenting findings, and assisting with complaint resolution for commercial medical devices, combination products, and medicinal products. Partners with cross-functional stakeholders to ensure complaint processes are executed in compliance with applicable regulations, GMP requirements, and internal procedure. Key Job Responsibilities Support the intake, documentation, coordination, investigation, resolution, {replacement/reimbursement} and closeout) of Product Quality Complaints in timely manner that complies with Otsuka requirements and Regulatory requirements (21CFR Parts 210, 211, 820, 803). Support the PQC distribution mailbox as well as complaint mailbox Assist with Complaint Sample retrieval Follow-up with Complainant (Patient, Sales Reps, Hospitals, Pharmacies and Physicians etc.) to obtain applicable information pertaining to reported events. Escalate complex or sensitive interactions to senior team members when appropriate Summarize complaint files to ensure proper documentation, coordination, investigation, resolution, which adheres compliance to regulatory requirements as well as Otsuka requirements. Assist with Critical complaints including notification to management in accordance with established procedures, follow-up with the reporter as required. Assist in the review of compliant documentation to ensure proper triage and provide feedback to management if any discrepancy is found. Assist in monitoring complaints for product trends and notify management of events requiring immediate Action. As applicable, support with conducting trend investigation. Support monthly and quarterly PQC metrics for all products. Engage and coordinate metrics for QRT meetings and compile meeting notes. Manage and update product FAQ documents based upon complaint type. Support with compiling and maintaining data used for Risk Management metrics for Drug/Device combination product and Medical Device product. Support with the evaluation of complaints for evidence of device malfunction, performance deficiencies, or use-related issues, and ensure timely escalation for further review and investigation as required Support any potential recall and/or reporting action activities. Support reconciliation processes in coordination with other teams (call center, Pharmacovigilance, and medical information etc.) to ensure it meets procedure requirement and timely completion. Ensure complaint records are accurate, complete, and maintained in accordance with applicable procedures, record retention requirements, and data integrity principles. Support, manage and complete assigned projects in accordance with Otsuka requirements. Support Internal GMP audit and External Regulatory inspections. Complete all assigned training in a timely manner Knowledge/ Experience and Skills: Required: Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820, 803) specifically those applicable to complaint handling, investigations, and documentation Abilify to manage multiple investigations simultaneously Analytical, problem solving, and troubleshooting skills with process optimization and improvement mindset Preferred experience with electronic quality systems (TrackWise complaints module, Veeva Vault, etc.) Proficient in MS Office software Strong interpersonal and communication skills, writing skills and ability to multitask. Ability to work in a team environment. Educational Qualifications Preferred Bachelor’s Degree with 3+ years of Quality Assurance experience including product quality complaint investigations in the pharmaceutical and/or medical device industry 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. 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 $89,622.00 - Maximum $128,800.00, 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. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112. Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591 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 EEAccommodations@otsuka-us.com. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. 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 have earned us certification as a Great Place to Work by the Great Place to Work Institute.