Director, Quality and Regulatory Compliance

April 3

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CREO

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CREO is a management consulting and advisory firm specializing in the life sciences and healthcare sectors. The company collaborates with leading life sciences and healthcare organizations to foster innovation in human health. By providing services in strategy development, M&A, product launch, digital transformation, cybersecurity, and IT compliance, CREO aims to unlock the growth potential of its clients. The firm is recognized for its holistic approach, which integrates growth management, people development, and technology to help companies navigate complex challenges and achieve their business objectives. CREO is committed to driving tangible value and advancing science through its expert consulting solutions.

Management Consulting • Executive Consulting • Leadership Development • Business Strategy • Mergers & Acquisitions

51 - 200 employees

Founded 2015

📋 Description

• The Director, Quality and Regulatory Compliance, will lead a team responsible for delivering consulting services and guidance to clients on GxP Quality and Regulatory compliance across the Life Sciences value chain. • This leader will directly manage staff performance, develop strategic plans, and set expectations to ensure client satisfaction. • The Director will develop and execute go-to-market plans that result in an expanded project portfolio with existing and new clients. • The leader is responsible for developing business (aligned to annual commercial targets). • In addition, the Director will support and lead a variety of projects, working closely with the leadership team, to recommend solutions to our client’s most complex challenges. • The Director will have a strong knowledge of global GxP Quality and Regulatory Compliance requirements across clinical research, pharmaceutical development, manufacturing, and laboratory services. • The Director will design strategies, establish implementation solutions and plans, and ensure successful project delivery across the dimensions of scope, schedule, budget, and quality. • The Director will interface with client executive leaders, subject matter experts, and technical staff to translate requirements, issues, and the value of proposed solutions. • This leader will have demonstrated experience and ability to prepare and present Board level materials and will have expert-level quantitative, Excel and PowerPoint skills and meet client deadlines and deliver impeccable results.

🎯 Requirements

• 12+ years of life science experience with 10+ years of QA and QC experience. • 10+ years’ experience in a “seller/doer” role where annual individual sales credit and delivery credit (of projects aligned with CREO’s service offerings) was each repeatedly $1M or greater • Demonstrated experience as a management consultant with deep life science quality and regulatory expertise. • Sales/business development experience must include significant prospecting, project scoping & pricing, proposal/SOW writing & presenting, and closing sales (note: experience “hunting” is strongly favored over “farming”) • Strong understanding and experience with GxP quality compliance (GMP, GCP & GLP) • Strong understanding and experience with one or more data privacy-related regulations, such as HIPAA, GDPR, CCPA, POPIA or PIPL. • Understand the business and technology challenges in growth-oriented life sciences businesses – specifically small/emerging biotech, biopharma, and pharma services (labs, CRO, CDMO, SMO, data providers). • Understands the challenges of both inorganic and organic growth. • Understanding of healthcare, payers, and providers is a plus. • Strong cultural awareness and ability to adapt speaking style and mannerisms for different clients. • Preference given to candidates who have experience working with or for companies owned by private-equity firms. • Well-developed expertise and experience in recruiting, interviewing, hiring, managing, and developing individual staff. • Well-developed expertise and experience building and managing a team of consultants to deliver exceptional client results.