Director, Quality and Regulatory Compliance
Remote
Full Time
Senior Manager/Supervisor
JOB DESCRIPTION OVERVIEW
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.
POSITION RESPONSIBILITIES
REQUIRED QUALIFICATIONS, SKILLS, AND EXPERIENCE
The following are critical elements of experience for the Director, Quality and Regulatory Compliance:
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.
POSITION RESPONSIBILITIES
- Business Development Excellence
- Sells and leads a $1M+/year individual book of business (within 2 years for newly hired Directors)
- Networks and prospects relentlessly to maintain robust pipeline of viable projects
- Scopes, prices and presents proposed SOWs to align with clients’ affordable needs
- Collaborates with colleagues on opportunities to optimize chance of contract signing
- Maintains accurate pipeline detail using corporate tools
- Build and Mature the Quality and Regulatory Service Offerings
- Identify key services, develop a service menu, create go to market materials, and develop standard delivery frameworks and reusable materials
- Ensure delivery teams understand the defined methodologies and gather input to continuously improve services.
- Client Service Excellence
- Ensures engagements are delivered according to the SOW and that all reasonable expectations of client have been met or exceeded
- Achieves billable utilization targets for self and assigned team members while prioritizing client satisfaction
- Maintains accurate revenue and expense forecasts for their book of business
- Ensures target project margins are achieved through appropriate project pricing and project staffing
- Team Members Management Excellence
- Exemplifies the firm’s core values, without exception, celebrating the same in colleagues and holding assigned team members accountable for any misaligned behaviors
- Ensures professional development plans for self and assigned team members are practical, resourceful and aligned with strategic growth objectives of the firm and its clients
- Hires and retains a high-function consulting team that meets or exceeds its capacity utilization target and surges, when necessary, when capacity is constrained
REQUIRED QUALIFICATIONS, SKILLS, AND EXPERIENCE
The following are critical elements of experience for the Director, Quality and Regulatory Compliance:
- Bachelor’s degree in science, engineering, other technical discipline, or equivalent industry experience. Master’s degree preferred.
- 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. Ability to lead teams with a sound work ethic, intellectual curiosity, and exceptional client service
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