Senior Manager, Quality Validation

Required Skills, Experience and Education

• A Bachelor's degree in a scientific, engineering or technical discipline is required.

• A minimum of 8 years of experience in the pharmaceutical industry demonstrated experience in GMP Quality and commercial manufacturing operations.

• Demonstrated experience providing QA oversight of validation lifecycle activities, with strong experience in Process Performance Qualification (PPQ) and Continued Process Verification (CPV); experience with packaging, cleaning, and transportation/shipping validation is preferred.

• Experience providing Quality oversight of CMOs and external partners supporting commercial manufacturing, packaging, testing, and validation activities.

• Strong knowledge of process validation lifecycle principles and applicable U.S. and global GMP regulations, regulatory guidance, and industry practices.

• Experience supporting commercial readiness, inspection readiness, and regulatory inspections, including domestic and international health authorities.

• Demonstrated ability to critically evaluate complex technical and compliance issues, assess risk, and make sound, risk-based Quality decisions.

• Strong communication, collaboration, and stakeholder management skills, with the ability to effectively work with cross-functional teams and external partners.

• Ability to work independently, manage multiple priorities and aggressive timelines, and effectively escalate significant quality and compliance risks.

• Proficiency with electronic quality systems and Microsoft Office applications.

1. 1

   Provide QA oversight of validation activities across CMOs and external partners supporting RevMed commercial products, including Drug Substance (DS), Drug Product Intermediates (DPI), Bulk Drug Product (BDP), Finished Product (FP), and Packaged Product, with primary emphasis on Process Performance Qualification (PPQ) and Continued Process Verification (CPV).

2. 2

   Serve as the QA Validation representative for assigned commercial programs and external manufacturing sites, providing oversight and approval of validation lifecycle activities, including PPQ, CPV, cleaning, packaging, and transportation/shipping validation, and ensuring activities are appropriately planned, executed, documented, and maintained throughout the commercial product lifecycle.

3. 3

   Provide QA review and approval of validation plans, protocols, reports, risk assessments, process performance evaluations, and associated investigations and change controls; review CPV data and process performance trends to confirm continued process control, identify emerging risks, and ensure appropriate investigation and escalation of adverse trends.

4. 4

   Represent QA on cross-functional teams and partner with internal and external stakeholders to address validation strategy, planning, technical issues, and compliance risks, providing guidance consistent with current global regulatory requirements, industry standards, and best practices.

5. 5

   Provide QA oversight and support for broader GMP Quality activities, including deviations, investigations, CAPAs, change controls, specifications, master and executed batch records, validation documentation, and other quality system activities supporting commercial manufacturing and product lifecycle management.

6. 6

   Establish, monitor, and communicate validation and process performance metrics, including PPQ/CPV status, trends, risks, and compliance issues, and escalate significant concerns to Quality leadership.

7. 7

   Lead or support the development, periodic review, and revision of GMP procedures and participate in inspection readiness activities, regulatory inspection support, and other commercial readiness initiatives as needed.

8. 8

   Build trusted, collaborative relationships with internal and external stakeholders that promote open communication, teamwork, and effective execution.