Sr. Consultant, CMC

Sr. Consultant, Quality 

PAI/PLI Audit Experience

CMC

*This is a contract role.

*This position will close on April 3, 2025.

Position Summary:

The Sr. Consultant, Quality is responsible for providing oversight and guidance on behalf of our client for the development, manufacturing, and testing processes of drugs or biologics to ensure product quality and compliance with regulatory requirements for new and mature products and interacting with regulatory agencies by providing strategic input, risk assessments and overseeing preparation of regulatory submissions.  

Duties and Responsibilities:

• Provide on-site and remote quality and product auditing at client facilities and client CDMOs world-wide.
• Serve as a regulatory, quality and technical CMC expert to clients.
• Review, advise and/or manage quality events such as lab investigations, deviations, change controls, CAPAs, etc..
• Author and/or review quality related documents as needed, including protocols, reports, and memoranda.
• Review, advise and/or manage reference materials including monitoring retest date, facilitating qualification/requalification, tracking inventory
• Review, advise and/or support quality systems and requisite documentation as needed.
• Review, advise and/or support on facilities and equipment quality systems and documentation as needed.
• Collaborate with cross functional teams including Process R&D, Pharmaceutical Development, Toxicology, and Quality Assurance to timely achieve project goals.
• Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biopharmaceutical, drug and combination products, to expedite submission, review and approval of CMC applications.
• Represents CMC in project team meetings and provides regulatory guidance and perspective to the cross-functional team.
• Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
• Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and standard guidelines
• Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
• Has accountability for information submitted in marketing applications to meet client requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
• Provide due diligence advice and auditing for legal and/or M&A requests.
• Opportunities to participate in the entire development plan builds from pre-IND, IND, BLA/NDA and commercialization.
• Opportunity to serve on cross-functional teams that include nonclinical, clinical, regulatory affairs and operations.
• Stays abreast of changing trends and current events within the industry. Formulates novel approaches and influences people, systems, and processes.
• Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
• Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems.
• Builds collaborative relationships with stakeholders and manage the internal and external teams responsible for delivery and develop junior team members

Anticipated travel requirements for the position will be approximately 50% based on client requirements. This is a ‘remote work’ independent contractor role.

Qualifications:

• Previous, recent experience within FDA as a field inspector or product reviewer inspector within the last 5 years is required.
• PLI or PAI audit experience within the last 5 years is required.
• Terminal degree required in one of the following or related areas: Biochemistry, Biotechnology, Molecular Biology, Biotechnology Engineering, Biology, Chemistry, Pharmaceutical Sciences, or other related fields is required. 

• Subject matter expert in CMC quality required.
• Minimum of 10 years combined relevant experience in quality assurance and regulatory/GxP compliance.
• Solid understanding of relevant FDA and ICH regulatory guidelines.

• Excellent verbal and written communication skills. 
• Excellent soft-skills in cross-functional management and client relation interactions. 
• Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation.
• Ability to manage organizational change.

• Comprehensive knowledge of CMC regulatory requirements for biologics and small molecules during development and post- approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products
• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues
• The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients.