Jubilant Pharma Limited
Manufacturing Compliance Manager
Jubilant Pharma Limited, Spokane, Washington, United States, 99254
Join to apply for the
Manufacturing Compliance Manager
role at
Jubilant Pharma Limited .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well‑established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries.
The company is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts, and is a proud member of the Jubilant Pharma family.
Job Description The
Manufacturing Compliance Manager
will adhere to compliance and regulatory standards regarding deviation investigations, root causes, corrective actions, change management, human error reduction, and driving initiatives for timely completion of deliverables.
This critical role maintains compliance within manufacturing, ensures regulatory readiness, and fosters strong partnerships with internal and external stakeholders.
Serve as a manufacturing compliance liaison between internal departments and external clients/auditors to ensure alignment on quality expectations, issue resolution, and maintaining compliance with deviation investigations and closure.
Oversee employees investigating deviations, assigning tasks, coaching and mentoring staff, and monitoring performance and KPIs.
Monitor and assess CMO performance through audits, quality metrics, and periodic reviews.
Perform data entry, analysis, and generate reports, presentations, and summaries for executive leadership.
Ensure manufacturing operates in compliance with cGMP, FDA, and other applicable regulatory standards.
Support external audits, regulatory inspections, and internal quality reviews related to operations.
Review and approve CMO documentation including SOP revisions, deviations, CAPAs, and change controls.
Support technology transfers and product launches, providing consultation to project teams for process improvements.
Negotiate solutions and influence decisions and outcomes.
Track and report compliance trends, risks, and improvement opportunities to senior leadership.
Must be proficient with Trackwise deviation, CAPA, and change control modules.
Must be proficient with SAP.
Establish a method/frequency for touchpoints/follow‑ups during off‑shifts.
Communicate in support of batch release for priority deliverables.
Support applicable compliance areas of manufacturing as needed.
Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; high school equivalent education with 10+ years progressive experience is also considered.
Investigation, Root Cause, Human Error Reduction training desired.
5+ years related CMO/FDA/Pharmaceutical experience required.
2+ years in leadership position (Supervisor/Manager) required.
Quality Compliance and/or Quality Oversight experience desired.
Technical Writing desired.
Investigations experience desired.
Project Management experience desired.
Advanced vocational/specialized knowledge required.
Microsoft Word, Excel, PowerPoint required.
Data entry and data analysis experience required.
Trackwise experience required.
Compliance Wire experience required.
Master Control experience required.
SAP experience required.
Shift Weekday Days, Monday‑Friday.
Compensation & Benefits This is an on‑site, full‑time position located in Spokane, WA.
Hiring Wage: $102,075 – $149,700 annually, depending on experience, with opportunity for growth, promotion, and annual raises.
Medical, Dental, Vision, Flexible Spending, and Health Savings Accounts.
Life, AD&D, Short and Long Term Disability.
401(k) with company match.
Generous paid time off plan.
Employee Assistance Program.
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you require assistance applying for a position, please contact our HR Department at: JHS‑TalentAcquisition@jubl.com
#J-18808-Ljbffr
Manufacturing Compliance Manager
role at
Jubilant Pharma Limited .
Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well‑established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries.
The company is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts, and is a proud member of the Jubilant Pharma family.
Job Description The
Manufacturing Compliance Manager
will adhere to compliance and regulatory standards regarding deviation investigations, root causes, corrective actions, change management, human error reduction, and driving initiatives for timely completion of deliverables.
This critical role maintains compliance within manufacturing, ensures regulatory readiness, and fosters strong partnerships with internal and external stakeholders.
Serve as a manufacturing compliance liaison between internal departments and external clients/auditors to ensure alignment on quality expectations, issue resolution, and maintaining compliance with deviation investigations and closure.
Oversee employees investigating deviations, assigning tasks, coaching and mentoring staff, and monitoring performance and KPIs.
Monitor and assess CMO performance through audits, quality metrics, and periodic reviews.
Perform data entry, analysis, and generate reports, presentations, and summaries for executive leadership.
Ensure manufacturing operates in compliance with cGMP, FDA, and other applicable regulatory standards.
Support external audits, regulatory inspections, and internal quality reviews related to operations.
Review and approve CMO documentation including SOP revisions, deviations, CAPAs, and change controls.
Support technology transfers and product launches, providing consultation to project teams for process improvements.
Negotiate solutions and influence decisions and outcomes.
Track and report compliance trends, risks, and improvement opportunities to senior leadership.
Must be proficient with Trackwise deviation, CAPA, and change control modules.
Must be proficient with SAP.
Establish a method/frequency for touchpoints/follow‑ups during off‑shifts.
Communicate in support of batch release for priority deliverables.
Support applicable compliance areas of manufacturing as needed.
Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; high school equivalent education with 10+ years progressive experience is also considered.
Investigation, Root Cause, Human Error Reduction training desired.
5+ years related CMO/FDA/Pharmaceutical experience required.
2+ years in leadership position (Supervisor/Manager) required.
Quality Compliance and/or Quality Oversight experience desired.
Technical Writing desired.
Investigations experience desired.
Project Management experience desired.
Advanced vocational/specialized knowledge required.
Microsoft Word, Excel, PowerPoint required.
Data entry and data analysis experience required.
Trackwise experience required.
Compliance Wire experience required.
Master Control experience required.
SAP experience required.
Shift Weekday Days, Monday‑Friday.
Compensation & Benefits This is an on‑site, full‑time position located in Spokane, WA.
Hiring Wage: $102,075 – $149,700 annually, depending on experience, with opportunity for growth, promotion, and annual raises.
Medical, Dental, Vision, Flexible Spending, and Health Savings Accounts.
Life, AD&D, Short and Long Term Disability.
401(k) with company match.
Generous paid time off plan.
Employee Assistance Program.
Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you require assistance applying for a position, please contact our HR Department at: JHS‑TalentAcquisition@jubl.com
#J-18808-Ljbffr