QUALITY ASSURANCE/GCP/QMS MANAGEMENT CONSULTANT (MID- TO SENIOR-LEVEL CONSULTANT)

SciLucent, Inc. is an employee-owned (ESOP) scientific consulting firm based in Northern Virginia, delivering innovative solutions across all stages of drug development. We partner with clients to navigate the complexities of the pharmaceutical industry, helping them spend smarter, succeed sooner, and focus on what matters most: advancing science and improving patient lives.

As our Scientific and Regulatory Consulting practice continues to grow, we are seeking an experienced scientific professional with a strong background in Quality Assurance and Good Clinical Practice (GCP) compliance, particularly in support of development-stage programs. This individual will join our team of highly skilled consultants dedicated to delivering exceptional service and measurable results for our clients.

The ideal candidate is an enthusiastic, adaptable, and self-motivated professional with outstanding English communication skills and a commitment to reliability, agility, responsiveness, excellence, innovation, and quality. They thrive in a collaborative environment and are passionate about helping clients achieve success through practical, science-driven solutions.

Responsibilities of the position include:

• Provide Quality Assurance oversight of client outsourced development programs, including interfacing with vendors, review/approval of GCP documentation, and ensure Sponsor (client) compliance with phase-appropriate expectations.
• Conduct GCP vendor qualification and routine audits, as well as clinical investigational site and trial master file (TMF) audits on behalf of clients.
• Assist our clients in achieving and maintaining compliance with regulatory standards, developing, implementing, and optimizing their quality management systems, and enhancing overall quality.
• Lead development and implementation of a client's phase-appropriate Quality management Systems (QMS) and oversee QMS maintenance activities.
• Perform gap analysis of client's existing quality systems to support a phase-appropriate QMS.
• Author and review Standard Operating Procedures, Quality Manual, Forms, Work Instructions, as required.

The ideal candidate will have the following:

• Bachelor's degree in a relevant scientific field (e.g., biology, chemistry, biochemistry, etc.) is required.
• A minimum of 8 years in the pharmaceutical/biotechnology industry and/or consulting with at least 7 years in Quality Assurance and conducting GCP audits.
• A minimum of 5 years of project management experience demonstrating excellent skills to take ownership of leading multiple projects to successful completion while producing excellent work product quality, allocating adequate resourcing, and staying within budget.
• Excellent understanding and stage appropriate application of GCP regulations and ICH and Quality guidance documents.
• Excellent attention to detail and organizational skills.
• Strong computer skills (e.g., Microsoft Word, Excel, PowerPoint, etc.) and ability to acquire knowledge of job specific software.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

Preferred

• Experience relating specifically to development stage programing.
• Prior consulting or client-facing experience.
• RQAP, ASQ, or other applicable certification(s).

Employees work remote from their home office which must be located in the United States. Our most valuable resource is our people. We hire intelligent, creative, passionate professionals with an ardent desire to learn. At our core is collaboration, camaraderie, growth, and collective hard work, without egos. Our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development. Additionally, we offer the following benefits: medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO. The annual base salary for this position ranges from $85,000 - 175,000 depending on qualifications and experience. Any salary offered is based on internal equity, internal salary ranges, market data/ranges, applicant's skills and prior relevant experience, certain degrees, and certifications.

Please send a resume and cover letter to [email protected]. Applications without cover letters will not be reviewed.

SciLucent is an equal opportunity employer. We thank all applicants for their efforts in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.