Manager Validation QA

Scientific Protein Laboratories•Waunakee, WI

2d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manager Validation QA. The QA Validation Manager will lead and oversee the development, execution, and maintenance of validation programs within a biologics drug substance manufacturing environment. This role requires comprehensive experience across multiple validation disciplines, including equipment, process, computer systems, and cleaning validation. The Validation Manager ensures all validation activities comply with cGMP regulations, internal SOPs, and regulatory expectations, providing technical leadership to ensure the consistent production of high-quality biologics products.

Requirements

Required: Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
Required: 5+ years, minimum 2 years in Management

Nice To Haves

Preferred: Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
Preferred : 10+ years, minimum 2 years in Management

Responsibilities

Participate in establishing and maintaining company validation management principles, standards, and operational requirements (SOPs, templates, guidelines, etc.) to ensure alignment with current regulatory expectations.
Assist in maintaining and updating the Master Validation Plan (MVP) to ensure comprehensive coverage and appropriate review cycles.
Develop, implement, and maintain validation strategies and plans for equipment, processes, cleaning, and computerized systems.
Lead and manage cross-functional validation projects, ensuring on-time completion and compliance with regulatory requirements.
Review, approve, and maintain validation documentation including protocols, reports, change controls, and deviations.
Perform quality assessments of deviations, CAPAs, and change controls identified during validation activities to ensure timely handling in accordance with quality and validation requirements.
Collaborate with manufacturing, quality, engineering, and IT teams to ensure validation activities are integrated with operational requirements.
Monitor regulatory changes and industry best practices to identify opportunities for improving validation management processes.
Support regulatory inspections and audits by providing validation expertise and documentation.
Drive continuous improvement initiatives for validation processes and methodologies.
Ensure risk-based approaches are applied to validation programs, including qualification and requalification activities.
Support technology transfer and scale-up activities for new biologics products.
Participate in internal and external audits as validation subject matter expert.
Monitor industry trends, guidance documents, and regulatory updates to maintain compliance.
Lead root cause investigations and corrective actions related to validation deviations.
Manage validation-related budgets and resource allocation.