Sterile Pharmaceutical Manufacturing Regulatory SME
Job Description
Job Title: Sterile Pharmaceutical Manufacturing Regulatory SME
Department: Quality
Reports To: Chief Manufacturing Officer
Location: Onsite – Dallas, TX (Monday–Friday)
Sterile Pharmaceutical Manufacturing Regulatory SME Company Overview
A rapidly growing pharmaceutical manufacturing and compounding organization is building a next-generation platform focused on expanding access to safe, affordable medications. Operating as a 503B Outsourcing Facility, the organization emphasizes regulatory rigor, operational excellence, and patient safety.
Sterile Pharmaceutical Manufacturing Regulatory SME Position Summary
The Sterile Pharmaceutical Manufacturing Regulatory SME serves as the senior technical authority for regulatory compliance in aseptic sterile drug manufacturing. This role leads regulatory strategy, inspection readiness, and execution of quality systems within a 503B Outsourcing Facility environment.
The position requires deep expertise in sterile parenteral manufacturing, USP sterile compounding standards, and FDA regulatory expectations, combined with the ability to implement scalable quality operations in a high-growth environment.
Sterile Pharmaceutical Manufacturing Regulatory SME Key Responsibilities
Regulatory & Technical Authority
- Serve as the primary SME for sterile parenteral drug manufacturing conducted under aseptic processing standards.
- Interpret and implement FDA 503B guidance, USP <797>, USP <800>, USP <71>, and 21 CFR Parts 210/211.
- Translate regulatory requirements into effective operational controls, procedures, and quality systems.
Inspection Readiness & Audit Leadership
- Act as Lead Management Representative and technical authority during FDA, state board, and external inspections.
- Maintain sustained inspection readiness across facilities, documentation, validation, and training programs.
- Lead regulatory responses, observation remediation, and CAPA execution.
Quality Operations Oversight
- Own batch record review, release, and disposition of compounded sterile products (CSPs).
- Oversee deviation management, CAPA, change control, complaints, investigations (OOS/OOT), and recall readiness.
- Ensure environmental monitoring, contamination control, and aseptic processing practices meet regulatory expectations.
Validation & Sterile Facility Controls
- Review and approve validation strategies for cleanrooms, HVAC, utilities, sterilization processes, equipment, and aseptic operations.
- Ensure facility qualification, media fills, and contamination control strategies support sterility assurance.
Distribution Compliance
- Maintain compliance with Wholesale Drug Distribution regulations and licensing requirements.
- Ensure traceability, documentation integrity, and audit readiness across distribution operations.
Leadership & Culture
- Provide technical leadership and mentorship to quality personnel.
- Promote a culture of compliance ownership, operational discipline, and continuous improvement.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related discipline (advanced degree preferred).
- Minimum 8+ years of hands-on experience in aseptic processing of sterile drugs for human use.
- Minimum 5+ years in a leadership or senior technical quality role.
- Expert, working knowledge of:
- FDA Section 503B and related guidance
- USP <797>, USP <800>, and USP <71>
- State Board of Pharmacy regulations for outsourcing facilities
- 21 CFR Parts 210/211 and sterile drug cGMP requirements
- Demonstrated success leading FDA inspections and regulatory audits.
- Strong documentation, technical writing, and cross-functional leadership skills.
Sterile Pharmaceutical Manufacturing Regulatory SME Key Competencies
- Regulatory Leadership and Technical Authority
- Aseptic Sterile Manufacturing Expertise
- Risk Management and Compliance Strategy
- Inspection Readiness & Audit Defense
- Operational Execution in Scaling Environments
- Continuous Improvement Mindset
- Cross-Functional Collaboration
- People Leadership and Team Development
Sterile Pharmaceutical Manufacturing Regulatory SME Why Join
- Direct ownership of regulatory and quality strategy in a growing sterile pharmaceutical operation
- High-impact leadership role with executive visibility
- Opportunity to build and mature quality systems in a rapidly scaling platform
- Mission-driven focus on improving medication access and affordability