Job Details

divh2Senior Manager Of Global Quality Management/h2pThe Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle./ph3Key Responsibilities/h3pClinical Study Support/pulliServe as a GCP quality resource to clinical teams during study planning, conduct, and close-out./liliSupport the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance./liliAssist in identifying and resolving quality issues, protocol deviations, and potential noncompliance./liliCollaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle./li/ulpInspection Readiness/pulliSupport inspection readiness activities including mock audits, documentation reviews, and training coordination./liliMaintain inspection readiness tools, trackers, and communication plans./liliParticipate in regulatory inspections and assist in preparing response documentation./li/ulpAudit Program Execution/pulliContribute to the development of the annual audit plan using risk-based approaches./liliCoordinate and support investigator site, vendor, and internal process audits./liliTrack audit findings and ensure timely implementation of corrective and preventive actions (CAPAs)./liliMonitor audit trends and escalate recurring issues to senior leadership./li/ulpQuality Systems Compliance/pulliSupport the implementation and continuous improvement of clinical quality systems, SOPs, and policies./liliAssist with deviation management, root cause analysis, and CAPA tracking related to clinical activities./liliStay current with evolving global GCP regulations and industry best practices./li/ulpCollaboration Team Support/pulliPartner with internal stakeholders and CROs to ensure consistent quality oversight./liliMay mentor junior staff or contractors./liliContribute to cross-functional initiatives that promote a culture of quality and compliance./li/ulh3Qualifications/h3pRequired/pulliBachelors degree in life sciences or related field; advanced degree a plus./lili68 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry./liliSolid understanding of GCP, ICH guidelines, and global regulatory requirements./liliExperience supporting inspection readiness and participating in audits or inspections./liliStrong communication, organizational, and problem-solving skills./liliAbility to travel domestically and internationally as needed./liliProficiency in MS Office (Word, Excel, PowerPoint)./li/ulpPreferred/pulliExperience with TrackWise or similar quality management systems./liliPrior collaboration with CROs and external vendors./liliExposure to FDA or other health authority inspections./li/ulh3Competencies/h3pAccountability for Results/ppStay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change./ppStrategic Thinking Problem Solving/ppMake decisions considering the long-term impact to customers, patients, employees, and the business./ppPatient Customer Centricity/ppMaintain an ongoing focus on the needs of our customers and/or key stakeholders./ppImpactful Communication/ppCommunicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka./ppRespectful Collaboration/ppSeek and value others perspectives and strive for diverse partnerships to enhance work toward common goals./ppEmpowered Development/ppPlay an active role in professional development as a business imperative./ppSalary Range: Minimum $131,153.00 - Maximum $196,075.00, 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 candidates 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./ppApplication Deadline: This will be posted for a minimum of 5 business days./ppCompany 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./ppOtsuka 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 Accommodation Request (...@otsuka-us.com)./ppStatement 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 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 Otsukas call center at: 800-###-####. 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: or your local authorities./p/div