Fractional Quality & Regulatory Leadership
Summit Quality & Compliance provides director-level quality and regulatory leadership to cell and gene therapy, pharmaceutical, and medical device manufacturers on a fractional basis. The firm's principal leads every engagement himself. His career has been spent inside the GMP operations of the same industries Summit serves.
The consultant you meet is the consultant who performs the work. There is no bench behind him.
Summit's principal currently holds a senior quality leadership position in regulated manufacturing.
Engagements end with working systems in place, not a report that someone else has to carry out.
A quality system is judged by how it performs under inspection, not by how it reads in a binder.
That principle guides every Summit engagement, from the first assessment to the last validated workflow.
Services
Most clients come to Summit for one of four reasons. They need to know where their quality system stands, they need someone senior to run it, they need help recovering from findings, or they want to modernize how it operates.
A structured evaluation of where the quality system stands today.
Summit evaluates quality systems against 21 CFR GMP requirements and the ISO standards that apply to your products. Findings arrive as a prioritized roadmap with honest timelines, written for the leadership team that has to act on it. Each assessment has a fixed scope and a defined end date, so the cost and the timeline are known before work begins.
Includes: QMS gap assessments · inspection readiness reviews · CAPA and deviation system evaluation · supplier quality assessment
Ongoing, embedded ownership of the quality function.
This is the core of the practice. Summit runs the quality function at a director level for a set portion of each month, sized to the stage of the company. A clinical-stage gene therapy developer and a commercial pharmaceutical site need very different quality programs, and the engagement is built accordingly.
Includes: quality system ownership · CAPA, deviation, and change control leadership · validation and computer system validation oversight · audit and inspection leadership
Restoring quality systems after findings or neglect.
When an inspection produces observations, the response plan matters as much as the fix. Summit builds remediation plans with commitment dates the company can actually meet, works down aged CAPA and deviation backlogs, and rebuilds quality systems whose foundations no longer fit the business.
Includes: observation and finding response · CAPA backlog recovery · quality system rebuilds · data integrity remediation
Governed automation and AI for regulated quality operations.
Summit writes the governance that regulated companies need before they put AI and automation to work in quality operations. It also builds the workflows themselves, validated and documented to hold up under regulatory scrutiny. Few quality consultancies do both.
Includes: AI governance frameworks and SOPs · quality process automation · implementation strategy · ongoing systems governance
Approach
Most quality consulting runs on a staffing model. A firm keeps a bench of consultants, an account team matches one to your project, and project managers sit between you and the person doing the work. The model scales well for the firm. It serves clients unevenly.
Summit is built differently. The firm's principal leads every engagement himself, from the first conversation to the final deliverable. There is no bench, no handoff, and no account layer.
That structure limits how many clients Summit can serve at one time, and the limit is deliberate. Each engagement receives senior attention for its full duration, and the person making the recommendations stays to carry them out.
It also keeps the counsel current. Summit's principal holds an active senior quality leadership position in regulated manufacturing, so the guidance reflects how inspections, standards, and technology expectations work now, not how they worked when a consulting career began.
Leadership
Barry Conner spent the bulk of his career in biotechnology and pharmaceutical GMP operations, with particular depth in cell and gene therapy. His work later extended into medical device manufacturing, where he serves as a Senior Director of Quality and Regulatory Affairs.
Across those sectors he has personally owned the functions that decide whether a quality system holds up under inspection: CAPA, supplier quality, validation and computer system validation, change control, and the audits and inspections themselves.
He founded Summit so that companies too early for a full-time quality executive could still have one. He also brought along a capability few quality consultants offer. When automation is the right answer, he designs and builds it rather than recommending it and leaving.
Sectors
Phase-appropriate GMP quality systems for advanced therapy developers. Rigor where regulation demands it, proportion where clinical stage allows it, and a design that can grow into commercial operations without being rebuilt.
Quality systems, CAPA, data integrity, and supplier quality programs built to perform under FDA inspection, from clinical supply through commercial manufacture.
Quality systems aligned to ISO 13485 and ISO 14971, informed by current, active device quality leadership experience.
Contact
An initial consultation is a brief, direct discussion of where your quality system stands and whether Summit is the right fit for what it needs. If it is not, you will hear that candidly.
Schedule a Consultation