Reporting to the VP of Global Quality Systems, this highly visible individual contributor role serves as the subject matter expert (SME) for Quality Assurance and Quality Control activities related to manufacturing, release and testing of drug product in compliance with cGMP. Leads the development and implementation of required procedures, processes and documentation in compliance with applicable drug regulations/guidelines. Responsible for Quality oversight of drug substance and drug product CMOs as well as analytical laboratories. Performs disposition of batch production records, conducts internal and supplier quality audits and proactively manages issues and risks to company goals and objectives. In addition, this key role leads/participates in audit readiness activities for mock audits, FDA pre-approval inspection and commercial launch of the drug product.
• Subject Matter Expertise in Investigational/Commercial Drug product Quality and Compliance.
• Expand the existing quality system to include cGMP requirements and create/update necessary SOPs, forms and documents and ensure ongoing compliance to FDA cGMP (primarily) as well as EMA and MHRA directives/ regulations for drug products.
• Quality oversight of contract manufacturing organizations (CMOs) and analytical laboratories utilized for drug product manufacturing, packaging, labeling and testing.
• Perform disposition of batch production records including review of any associated deviations, investigations and CAPAs to release product for distribution.
• Review and approve method validations, change control, CAPA, deviations and investigations, in collaboration with CMOs.
• Conduct internal and supplier quality audits for compliance to applicable drug regulations/ guidelines.
• Ensure a clear understanding of pre-approval regulations and requirements to proactively identify and help resolve any Quality/Compliance related issues to meet company/project goals and objectives within pre-established timelines.
• Provide Quality oversight and guidance for cross-functional technical projects pertaining to the drug product.
• Collaborate with Regulatory Affairs and cross functional teams to ensure appropriate execution of CMC strategy and preparation of risk assessments as needed.
• Stay current with cGMP requirements, emerging regulations, standards, or guidance documents for drug product and initiate process improvements as appropriate.• Ensure compliance with corporate policies and internal procedures, as well as US healthcare laws and regulations.
• Other miscellaneous projects/activities as assigned.
• No direct reports, but position may manage external consultants if needed.
• Bachelor’s degree in biology, chemistry, engineering or other health-related discipline (Master’s degree a plus).
Experience / Knowledge / Skill Requirements
• 5-7 years of experience in the Quality function of a pharmaceutical company (sterile manufacturing preferred).
• Experience in applicability of FDA 21 CFR 210 & 211 to ensure compliance to cGMPs.
• Experience in FDA inspections, internal/supplier audits and audit readiness activities.
• Experience in the oversight and management of CMOs and analytical labs.
• Experience with writing/editing effective SOPs and technical documents.
• Experience in supporting CMC related activities for a small company.
• Combination products (with medical device) experience preferred.
• Knowledge of EMA/MHRA and applicable ICH guidelines for Drug substance and drug product.
• Working knowledge of electronic quality management systems for documentation, change control and training.
• Excellent organization, communication (written and verbal) and interpersonal skills.
• Positive mindset, flexibility, and the ability to build cooperative working relationships with internal and external stakeholders in a startup environment.
• Ability to learn fast and work successfully within a team/collaborative environment, with a high level of professionalism and sense of urgency.
• Critical thinking and problem-solving abilities to propose practical and achievable solutions.
• Detail orientation with the ability to detect and correct errors and/or inconsistencies in documentation.
• Proficient in Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.
Physical Demands and Conditions Requirements
• General office environment. This position may be remote home-office based or company office based, depending on where the incumbent resides. It requires approximately 10-15% travel.
• General office equipment.
Interested candidates should submit their resume and cover letter to: email@example.com