Sr Mgr, Compliance & Validation

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. 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 Sr. Manager of Validation and Compliance is responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.

The Sr. Manager, Compliance and Validation ensures that all documentation systems (BM-RAM, SAP, Trackwise, etc.) demonstrate an appropriate state of control and compliance for all equipment, systems, facilities, and utilities. The Sr. Manager tracks compliance state of SOP reviews, requalifications, calibrations, Trackwise Quality system records, audit responses, and other documentation systems to escalate compliance gaps and help drive resolution of outstanding issues.

The Sr. Manager serves as the general oversight for the facility validation program. The individual ensures equipment is appropriate qualified for use and prioritizes assignments and allocates and assigns labor to support them.

This individual provides direction and instruction to both professional and non-degreed department staff members and is also responsible for evaluating their work. This individual may also be asked to participate in audits, which requires extensive contact with clients and members of regulatory agencies.

Primary responsibilities include:

• Validation Management: Overseeing the validation of manufacturing processes, equipment, and systems to ensure they meet regulatory and quality standards.
• Compliance Oversight: Ensuring that all qualification, maintenance, metrology and other records comply with regulatory requirements, including FDA, GMP, and other relevant standards.
• Documentation and Reporting: Preparing, reviewing, and maintaining detailed documentation of validation and compliance activities, including CAPAs, change controls, protocols, deviations, and reports.
• Audit and Inspection Support: Supporting internal and external audits and inspections to ensure compliance with regulatory standards.
• Training and Development: Designing and implementing training programs for staff on validation and compliance procedures.
• Continuous Improvement: Identifying areas for improvement in validation and compliance processes and implementing corrective actions.
• Project Management: Managing validation and compliance projects, including scheduling, resource allocation, and milestone tracking.

Qualifications

• Bachelors of Science
• 10+ years of pharmaceutical experience
• Office (Word, Powerpoint, Excel, Teams)
• Working knowledge of US and EU GMPs
• Works autonomously with high ownership, without regular direction.
• Supervises salaried and hourly staff
• Creative problem solving
• Managing conflicts, collaboration, and leading teams to solutions

Preferred Qualifications

• FDA Regulated Industry Experience
• 3-5 Years Managerial Experience
• Trackwise Quality Management System

Shift: Days

Compensation: The salary range for this position is $101,500 - $178,000 depending on experience. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibits outstanding performance over a period of time in the role
Benefits:

• 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

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

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:

Human.Resources@jubl.com