Interim Head

Interim Head at ProPharma Interim Head at ProPharma in Garrett Park, Maryland Posted in about 1 hour ago.

Type:

full-time

Job Description:

Job Title :

Interim Quality Head Start:

Asap Location:

Rockville, MD (100% onsite, M-F) Required skills/experience: Biotech, leadership experience. Cell and Gene Therapy experience is a plus. Objectives Embed commercial-ready quality behaviors, systems, and continuous improvement practices. Maintain quality program momentum and consistency during leadership transition. Coach and mentor staff in critical thinking, deviation management, and quality decision-making. Strengthen documentation standards and ensure inspection readiness. Establish a strong quality foundation for incoming leaders to build upon. Scope of Work Collaborate with Quality leadership to identify immediate operational and procedural priorities. Review and enhance key records (deviations, CAPAs, validation documents, batch records, etc.) to commercial standards. Facilitate coaching sessions focused on risk-based thinking and decision justification. Standardize templates, workflows, and review practices to improve clarity and consistency. Support leadership readiness by documenting processes, metrics, and lessons learned to aid transition. Out of Scope The embedded resource will not apply Quality signatory authority in [Client name] systems; final review and approval responsibilities remain solely with [Client name] Quality. The embedded resource will not manage personnel in any Quality or site systems; all personnel management, performance oversight, and decision-making concerning staff remain under the authority of [Client name] Quality leadership. The role is advisory and developmental, focused on coaching, guiding, mentoring, and enabling sustainable quality behaviors without assuming formal management or decision rights. Key Benefits During Leadership Transition Continuity and stability: Maintains momentum and oversight amid organizational transition.

Accelerated onboarding:

Provides structure, knowledge transfer, and context for incoming Quality leaders.

Risk mitigation:

Reduces compliance exposure through proactive review and coaching.

Capability uplift:

Improves quality ownership and consistency across functions.

Commercial readiness:

Ensures processes and documentation stay aligned with regulatory expectations during the staffing gap. Expected Outcomes Enhanced documentation quality, consistency, and compliance. Strengthened team proficiency in quality and regulatory practices. Reduced delays and escalation requirements for senior QA review. A stable, inspection-ready foundation for permanent Quality leadership. Duration and Deliverables Three-month embedded engagement with biweekly progress updates, targeted improvement reports, and a closing handover package