Excellence through Quality: Pharmavise, your strategic Life Sciences, Healthcare, and Government solutions partner.
GxP Senior Consultant – Subject Matter Expert
Location
United States
Posted
23 days ago
Salary
0
Seniority
Senior
Job Description
GxP Senior Consultant – Subject Matter Expert
Pharmavise Corporation
• Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations. • Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.). • Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations). • Design, execute, and oversee validation and qualification programs: Process validation Equipment qualification (IQ/OQ/PQ) Software/CSV (21 CFR Part 11) Cleaning and sterilization validation Computerized systems validation. • Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements. • Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks. • Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management. • Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables. • Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training. • Support change management, technology transfer, and scale-up initiatives for manufacturing and operations. • Travel to client sites as needed.
Job Requirements
- 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
- Recognized subject matter expertise in at least one of the following domains: Quality Assurance / Quality Systems Regulatory Affairs Validation & Engineering (Process, Equipment, Automation, CSV) Manufacturing Operations / Tech Transfer Clinical Operations & Compliance Risk Management (ISO 14971) Design Controls (21 CFR 820, ISO 13485)
- Strong working knowledge of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.).
- Proven ability to lead cross-functional projects and serve as a senior advisor for complex technical challenges.
- Prior experience in consulting, advisory, or client-facing technical leadership roles.
- Excellent communication, documentation, and presentation skills.
Benefits
- Equal Opportunity Employer
Related Guides
Related Categories
Related Job Pages
More Consultant Jobs
Clinical Consultant
Healthcare Provider Solutions, Inc.Healthcare Provider Solutions is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Role Description Our company is seeking a full-time REMOTE Clinical Consultant to work on our clinical consulting team. The ideal candidate for this job has a minimum of 2 years of experience in Home Health and Hospice Quality Assurance/Compliance reviews. Home Health Mock Survey experience is essential. - Participate in the completion of remote and on-site chart audits for clients regarding clinical, OASIS and billing issues. - Conduct ADR/UPIC/SMRC/OIG chart reviews for clients upon request. - Document summary reports regarding the results of these audits and forward them to both supervisor and client. - Conduct mock surveys for home health and hospice agencies. - Keep updated on Medicare home health and hospice issues utilizing websites, teleconferences, newsletters, magazines, etc. - Answer clinical questions from clients or potential clients that email questions. - Participate in any/all teleconferences, meetings, forums that focus on Medicare home health and hospice issues to maintain a high standard set for HPS staff. - Potentially, perform related research and writing of home health & hospice related articles for HPS Blog. - Professional candidate must be able to travel approximately 1/3 of the time. Qualifications - At least 2 years of experience in both home health and hospice auditing/compliance preferably the last two years. - Travel at least 1/3 of the time. - Registered Nurse or Therapist. - Preferably certified in OASIS. - Experience with Mock Surveys. - Experience in multiple EMR systems for home health and hospice HUGE PLUS. Benefits - Paid Time Off (PTO; starts accruing day one and is available for use following probationary period of 60 days). - Eleven paid holidays off per calendar year, including 2 floating holidays annually. - Company paid medical and life insurance policy for employee upon eligibility. - Dental, vision and dependent medical coverage offered to employee, at cost upon eligibility. - Retirement plan with company match available immediately upon hire. - Bonus eligible. - Salary-exempt. Company Description Healthcare Provider Solutions is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Epic PB/HB Consultant
Creative Information Technology, Inc.Creative Information Technology Inc (CITI) is an esteemed IT enterprise renowned for its exceptional customer service and innovation. We serve both government and commercial sectors, offering a range of solutions such as: Healthcare IT Human Services Identity Credentialing Cloud Computing Big Data Analytics With clients in the US and abroad, we hold key contract vehicles including: GSA IT Schedule 70 NIH CIO-SP3 GSA Alliant DHS-Eagle II Join us in driving growth and seizing new business opportunities. Preferred Qualification Prior experience working with public health agencies (e.g., CDC, NIH, or State Departments of Health) to modernize legacy data infrastructures.
Role Description Work as an analyst with our PB & HB teams to support PFS, SBO and Revenue Integrity Operations with their daily use of Epic. - Resolve help desk tickets. - Participate in Epic Quarterly releases (NN review, build, testing). - Assignments on system projects that require a PB or HB Analyst. Qualifications - Certification in Epic PB Admin for SBO and Charge Router is required. - Certification in HB Admin, CDM and HB Charge Router are a plus. - The priority is for PB, certainly a HUGE plus if the consultant also has HB certs and experience. Company Description Creative Information Technology Inc (CITI) is an esteemed IT enterprise renowned for its exceptional customer service and innovation. We serve both government and commercial sectors, offering a range of solutions such as: - Healthcare IT - Human Services - Identity Credentialing - Cloud Computing - Big Data Analytics With clients in the US and abroad, we hold key contract vehicles including: - GSA IT Schedule 70 - NIH CIO-SP3 - GSA Alliant - DHS-Eagle II Join us in driving growth and seizing new business opportunities.
Healthcare Foodservice Consultant
US FoodsUS Foods is a foodservice distributor, partnering with restaurants and operators to help their businesses succeed.
• Support US Foods goals to achieve new sales growth and penetrate existing business • Develop operating business plan and report monthly • Build customer relationships at foodservice director and c-suite levels • Utilize a consulting approach in the areas of contract maximization and operational challenges • Assist with customer business reviews • Develop and execute strategies utilizing Business/Menu Solutions tools • Work collaboratively with the Senior Specialists on local and regional projects
Consulting Case Team Lead
Hayden Consulting GroupHayden Consulting Group is a strategy and analytics consulting firm that partners with life sciences companies to untangle access complexity, uncover deep insights, and unlock commercial success. Our team of leaders is connected by a common thread – to redefine how the life sciences industry thinks about access. Placing access at the forefront of decision-making is critical to ease the process for patients and their providers to obtain clinically necessary therapies. We’re excited to lead the way, driving Access Forward.
Role Description At Hayden, Case Team Leads are responsible for managing projects, designing & executing analytical workplans, and mentoring our junior team. Throughout your tenure, you will be focused on mastering project oversight and moving into team leadership. Successful CTLs break down problems into issue maps, strategically evaluate information, and construct persuasive stories that have tangible and impactful meaning to our clients. While we focus on the life sciences industry, you will learn business & strategy foundations that can be applied broadly throughout your career. - Data Analysis & Research Mastery - Demonstrate mastery of technical skills and subject matter expertise - Design and execute against comprehensive analysis plans - Generating Insights & Storytelling - Distill complex information into meaningful & objective observations - Product Content & Delivery - Collaborate with your teammates to develop and deliver content - Project Management - Lead concurrent workstreams, making informed & data-driven decisions Qualifications - A problem-solver who seeks to maximize their strategic impact and identify creative solutions - An analytical thinker who makes sound decisions, sets clear priorities, and helps delegate workstreams & activities - A navigator of uncertainty who remains adaptable, curious, and open to learning - A coach who motivates others and enhances the capabilities within their teams - A focused listener who leverages tools, best practices, skill mastery, and consulting fundamentals to better understand their client’s needs Requirements - 3-4 years related experience in consulting, data analytics, or other relevant areas within the life sciences - A minimum of a bachelor’s degree - An advanced degree or educational experience desired - Understand analytics, analytical approaches, and how to interpret and enhance data analytics created by junior staff - A willingness or ability to travel as needed (15-20% on average) Compensation Your expected annual compensation for this level for base and bonus is between $155,000 and $168,000. In addition to your base salary and annual bonus, employer 401k match, and significant performance incentive awards which occur at time of promotion. Hayden considers many factors in our compensation decisions which include but are not limited to the following: individual skills set/job performance, organization and industry demand, individual experience level and training, and geographic location. Benefits - Competitive base salary plus annual bonus - Commuter benefit (for office-based/non-remote employees) - Medical, Dental, Vision, Short and Long-Term Disability insurance - 401(k) match - Educational Reimbursement Plan - Paid Company Holidays, Time-Off and Sick Time - Bereavement Leave - Time off to Vote - Paid Parental Leave - Employee Assistance Program (EAP) - Monthly cell phone reimbursement - Laptop & Home Office set-up - Employee led committees (DEI&A, Services, Social, Women’s Leadership Alliance) - Employee discounts - Additional recognition and rewards programs

