Contractor, Manager Quality Control

Manager, Quality Control (Hybrid)

We're looking for a Manager, Quality Control (QC) to support cGMP QC activities for small-molecule development and commercialization programs. This role is hands-on, execution-focused, and ideal for someone who thrives in a virtual, fully outsourced QC model with opportunities to grow into project leadership.

What You'll Do

• Support QC operations across development and commercial programs, including data review for starting materials, in-process testing, batch release, and stability.
• Manage QC documentation and workflows in Veeva, Veeva LIMS, Smart Sheet, Excel, and JMP.
• Contribute to APQRs, data trending, reference standard management, and batch disposition support.
• Assist with method transfer, qualification, validation, and analytical lifecycle documentation.
• Ensure QC data accuracy and traceability for Module 3 and regulatory submissions.
• Identify opportunities to improve QC processes and digital workflows.

What You Bring

• B.S. with 6+ years or M.S. with 4+ years in analytical chemistry or related field.
• Experience in QC and data management for pharmaceutical development or commercialization.
• Familiarity with HPLC/UPLC, GC, KF, UV/FTIR, dissolution, and other small-molecule analytical techniques.
• Strong understanding of cGMP requirements.
• Ability to work independently, stay organized, and manage multiple priorities.

Preferred

• Experience with CDMOs, solid oral dosage forms, oncology/orphan indications, or virtual QC models.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals.

We will not share your information with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.