Jubilant HollisterStier LLC
Manufacturing Compliance Manager
Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254
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. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.
Our Promise: Caring, Sharing, Growing We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.
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 initiative and collaboration for timely completions of deliverables. This important role is critical in maintaining compliance within manufacturing, ensuring regulatory readiness and fostering strong partnerships with internal and external stakeholders.
Serve as a manufacturing compliance liaison between internal departments as well as external clients and auditors to ensure alignment on quality expectations, issue resolutions and maintaining compliance of deviation investigating and closure.
Oversee employees investigating deviations, assigning tasks, coaching and mentoring employees 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 decision 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 some method/frequency for touchpoints/follow ups during off-shifts.
Communication in support of Batch Release for priority deliverables.
Support any applicable compliance area of manufacturing as needed.
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field, will consider high school equivalent education+ 10 year's progressive experience.
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, Data analysis experience required.
Track wise 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. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
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
Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
Please click on the Spokane, Wa. Link
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
Our Promise: Caring, Sharing, Growing We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.
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 initiative and collaboration for timely completions of deliverables. This important role is critical in maintaining compliance within manufacturing, ensuring regulatory readiness and fostering strong partnerships with internal and external stakeholders.
Serve as a manufacturing compliance liaison between internal departments as well as external clients and auditors to ensure alignment on quality expectations, issue resolutions and maintaining compliance of deviation investigating and closure.
Oversee employees investigating deviations, assigning tasks, coaching and mentoring employees 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 decision 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 some method/frequency for touchpoints/follow ups during off-shifts.
Communication in support of Batch Release for priority deliverables.
Support any applicable compliance area of manufacturing as needed.
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field, will consider high school equivalent education+ 10 year's progressive experience.
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, Data analysis experience required.
Track wise 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. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
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
Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
Please click on the Spokane, Wa. Link
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