Senior Manager, Compliance & Validation

Jubilant Pharma

10+ years

$101,500 - $178,000

Remote, USA

10 Jan. 27, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Manager, Compliance & Validation
Location: Spokane, Washington
Company: Jubilant HollisterStier LLC

About Us:
Jubilant HollisterStier LLC, part of the Jubilant Pharma family, is a well-established member of the Spokane business community, providing a complete range of services supporting the pharmaceutical and biopharmaceutical industries. We are a global leader in manufacturing allergenic extracts, focusing on treating allergies and asthma, and we are also a nationally recognized contract manufacturer of sterile injectable vials and lyophilized products.

Our Promise:
At Jubilant HollisterStier, we are committed to caring, sharing, and growing. We focus on delivering innovative products and economically efficient solutions while being environmentally and socially responsible.

Position Overview:
The Senior Manager of Compliance and Validation is responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and are suitable for their intended purpose. This role oversees validation and compliance systems, ensuring all documentation (e.g., BM-RAM, SAP, Trackwise) maintains an appropriate state of control. The Sr. Manager will identify compliance gaps, escalate issues, and drive resolution. The role also involves oversight of equipment qualification, prioritization of validation projects, and providing leadership to both professional and non-degreed staff.

Key Responsibilities:

Validation Management: Oversee the validation of manufacturing processes, equipment, and systems to ensure compliance with regulatory standards.
Compliance Oversight: Ensure qualification, maintenance, metrology, and other records meet regulatory requirements (FDA, GMP, etc.).
Documentation and Reporting: Prepare, review, and maintain detailed documentation related to validation and compliance activities, including CAPAs, change controls, protocols, deviations, and reports.
Audit and Inspection Support: Support internal and external audits and inspections, ensuring compliance with regulatory standards.
Training and Development: Design and implement training programs on validation and compliance procedures for staff.
Continuous Improvement: Identify and implement improvements in validation and compliance processes.
Project Management: Manage validation and compliance projects, including scheduling, resource allocation, and milestone tracking.

Qualifications:

Required:
- Bachelor's degree in a relevant field (e.g., Science, Engineering, or related discipline).
- 10+ years of experience in the pharmaceutical industry.
- Proficiency in Microsoft Office (Word, PowerPoint, Excel, Teams).
- Working knowledge of US and EU GMP regulations.
- Ability to work autonomously and take ownership of tasks and projects.
- Proven experience supervising both salaried and hourly staff.
- Strong creative problem-solving, conflict management, collaboration, and team leadership skills.
Preferred:
- Experience in an FDA-regulated industry.
- 3-5 years of managerial experience.
- Familiarity with Trackwise Quality Management System.

Compensation & Benefits:

Salary: $101,500 - $178,000, based on experience.
- Midpoint and above are for employees with longevity and demonstrated performance.
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.

How to Apply:
If you're looking for a dynamic and rewarding career, we welcome your application! Please send your resume to the HR Department at Human.Resources@jubl.com.

Jubilant HollisterStier is an Equal Opportunity 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 need assistance applying for this position, please contact our HR Department.

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Senior Manager, Compliance & Validation

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