Biologics QC Senior Manager - Global Submissions & CDMOs
Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Quality Control (Biologics) in Annapolis, Maryland. This role is pivotal in executing QC activities across various contract labs, ensuring compliance with cGMP and regulatory standards. The ideal candidate has extensive experience in biologics QC, strong knowledge of analytical methods, and a proven track record in managing regulatory filings. Responsibilities include oversight of QC interface with external partners and ensuring data integrity. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.
$134.62k - $201.25k
The Senior Manager, Quality Control (Biologics) will execute and support QC activities across CDMOs and contract testing labs within a virtual operating... .... It also supports global regulatory filings (IND/BLA/MAA) by delivering submission‑ready analytical strategies...SeniorContract workTemporary workLocal areaFlexible hours$230.72k - $345k
The Senior Director, Analytical Development... ...and lifecycle management. This leader is... ..., and external CDMOs, and plays a... ...and QC strategy across... ...strategies aligned with global regulatory expectations... ...regulatory submissions. Act as... ...molecules, peptides, biologics). Oversee...SeniorTemporary workLocal areaFlexible hours$150.03k - $224.25k
...investigational, new and marketed biologic and small molecule drug... ...maintained in compliance with global regulatory requirements and guidances... ...for CMC and GMP related submissions and inquiries. Represents... ...regarding CMC issues. Independently manage preparation of INDs, BLAs,...SeniorContract workTemporary workWork at officeLocal areaFlexible hours$169.22k - $253k
...Summary The Director, Global Product Quality - Manufacturing... ...commercial products at CDMOs under contract by... ...Small Molecule and Biologics products Establishes and... ...of Quality Systems for managing the batch record review... ...escalates quality issues to senior management when...SuggestedContract workTemporary workLocal areaFlexible hours$95k - $210.9k
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...limited supervision, the Senior Regulatory Specialist... ...critical and complex global regulatory projects... ...and maintaining product submissions and regulatory filings... ...labeling and claims. Manage individual projects by... ...in life science field (biology, microbiology, chemistry...SeniorMinimum wageLocal areaWorldwide$132.7k - $303.2k
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$100k - $120k
...Planate Management Group (PMG) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) headquartered... ...combined experience as a Superintendent, QC Manager, Project Manager, or Project... ...opens you to an experience working for a Global company where you are among a team that...Full timeTemporary workFor contractorsFor subcontractorWork at officeWorldwide- North Eastern Services is looking for a Quality Control Manager to oversee the quality control process in solar project development in Maryland. Responsibilities include conducting site visits, reviewing project materials, and ensuring compliance with quality guidelines...Remote job
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Quality Manager I, Customer Hybrid 50/50 capacity at our Global Headquarters in Hunt Valley, Maryland. Position Overview Customer Quality Managers are responsible... ...of Education and Discipline: BA in Chemistry, Biology, Food Science, or related field Experience: Minimum...Permanent employmentWorldwide- ...NFRC is an ISO/IEC 17065-accredited product certification body serving the fenestration industry. The Senior Manager of Quality Assurance leads the function that protects the integrity of NFRC's certification program, from accreditation maintenance to internal audit to...Senior
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...have opportunities to work on systems that impact people’s lives globally. The company pioneered many technological advancements, from... ...Overview Northrop Grumman Mission Systems seeks a Principal or Senior Principal Embedded Software Engineer to develop software for cutting...SeniorRelocation packageShift work- Otsuka America Pharmaceutical Inc. is seeking a Director, Global Product Quality in Annapolis, Maryland. This role leads quality oversight... ...field. Responsibilities include ensuring supplier compliance, managing product quality issues, and collaborating across departments....
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