Careers

Quality Assurance/GxP/QMS Management Consultant (Sr. Principal Consultant)

SciLucent, Inc., a partially employee-owned (ESOP) Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, is seeking an experienced scientific professional with a strong Quality Assurance and GxP compliance background with experience working on developmental stage programs to join our team of experienced professional consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.

Responsibilities of the position include:

• Assist our clients in achieving and maintaining compliance with regulatory standards, developing, implementing, and optimizing their quality management systems, and enhancing overall quality.
• Provide Quality Assurance oversight of client outsourced development programs, including interfacing with vendors, vendor qualification, and ensure Sponsor (client) compliance with phase-appropriate expectations.
• Lead phase-appropriate development, implementation, and  development of client  Quality management Systems (QMS); oversee QMS maintenance activities.
• Perform gap analysis of client’s existing quality systems and QA functions.
• Author and review Standard Operating Procedures, Quality Manual, Forms, and Work Instructions, as required.
• Conduct, resource, and manage GxP vendor compliance inspections/audits.
• Build SciLucent QA infrastructure/tools, service provision capabilities, and training program.
• Author, review, and/or approve GxP documentation as client QA representative.
• Interface with clients, vendors, and other functional groups to identify quality issues.

The ideal candidate will have the following:

• Master’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.) or equivalent relevant scientific/regulatory/quality experience, is required.
• A minimum of 13 years in the pharmaceutical/biotechnology industry and/or consulting with at least 10 years in Quality Assurance relating specifically to development stage programing.
• A minimum of 7 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.
• Experience in outsourced development program quality oversight and auditing.
• Excellent understanding and stage appropriate application of GCP and GMP regulations and ICH and FDA CMC 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.
• Excellent in identifying, developing, and growing a client base; building and cultivating repeat, long-term business relationships.
• Consulting experience and RQAP, ASQ, or other applicable certification(s) are desired.

Both local and remote applicants will be considered and are encouraged to apply. Our most valuable resource is our people. We hire intelligent, creative, passionate professionals with a strong desire to learn. At our core – 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 $145,000 – $250,000 depending on qualifications and experience.  Any offered salary 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.