Program Lead/Sterility Assurance Review Senior Consultant

ProPharma; Raleigh (NC); On-site; USD 120,000 - 170,000; Part time

Benefits offered by this job

Hybrid work model

Equal opportunity employer

Job summary

ProPharma in Kansas City, KS seeks a senior lead for retrospective product reviews, focusing on sterility reviews, protocol development, and client communication. You will oversee a small team, coordinate cross-functional tasks, and ensure scientific rigor in the assessment of lot data and product impact.

The role requires 10+ years in sterile manufacturing with aseptic processing experience and FDA remediation knowledge.

Qualifications

• Experience leading sterile manufacturing and sterility assurance initiatives.
• Strong understanding of aseptic processing and regulatory remediation.
• Proven ability to oversee technical reviews and client communications.

Responsibilities

• Lead the sterility review team (2-3 people) and act as the primary client contact.
• Develop and finalize the review protocol and assessment methodology.
• Coordinate execution of retrospective review and deliverables.
• Provide technical oversight and review of lot assessments and product impact conclusions.
• Facilitate escalation of significant product-quality concerns and governance meetings.

Skills

Sterile manufacturing

Sterility assurance

Aseptic processing

FDA remediation

Technical oversight

Project leadership

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Location: Kansas City, KS (onsite)

Duration: 2-3 months

Scope:

Position will act as the overall lead for the retrospective product review workstream. Responsible for development of the review methodology, technical oversight of lot assessments, product impact evaluations, client communication, and final report review and approval. Duties include:

• Lead the sterility review team (2-3 people)
• Serve as the primary client point of contact and overall workstream lead.
• Develop and finalize the review protocol and assessment methodology.
• Coordinate execution of the retrospective review and associated deliverables.
• Provide technical oversight of the review process.
• Perform secondary review of lot assessments and product impact assessments.
• Review technical conclusions for consistency and scientific rationale.
• Facilitate escalation of significant product-quality concerns.
• Support preparation and finalization of interim reports and final deliverables.
• Participate in project governance meetings and status updates.

Years of Experience: 10 years

Key Experience Required: Sterile manufacturing, sterility assurance, product impact assessments, aseptic processing, FDA remediation

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you’re successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.