About the Role:
Responsible for providing Quality oversight and technical support for GMP manufacturing activities performed by Contract Manufacturing Organizations (CMOs), with a particular focus on packaging and labeling and shelf-life extension for clinical trial materials for global studies Independently executes and supports core quality processes including batch record review, deviation investigations, change control assessment, and support for new product introductions. Operates through technical expertise, collaboration, and sound quality decision-making to ensure compliance with cGMP regulations, internal quality systems, and regulatory expectations. May lead projects or initiatives through cross-functional influence but does not have direct people management responsibility.

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Your Contributions (include, but are not limited to):

Quality Operations & Technical Execution

• Independently review and approve quality records associated with GMP products manufactured by CMOs, ensuring compliance with cGMP regulations, internal procedures, and quality standards.

• Support timely and compliant batch disposition activities through review of batch documentation, investigation outcomes, and supporting quality data.

• Assess and escalate quality risks, compliance concerns, and potential product impact issues to senior QA leadership as appropriate.

• Execute quality oversight activities supporting GMP manufacturing operations and associated quality systems.

Cross-Functional Collaboration

• Serve as the Quality representative on assigned cross-functional teams and initiatives, providing Quality guidance and supporting issue resolution activities.

• Support Quality activities related to new product introductions (NPI), process validation, scale-up activities, technology transfers, and lifecycle management initiatives.

• Collaborate with internal stakeholders and external partners, including CMOs and suppliers, to facilitate resolution of quality issues and maintain alignment with quality expectations.

Investigations, Change Control & Compliance

• Conduct deviation investigations and support root cause analysis activities using established investigation methodologies and risk-based approaches.

• Provide Quality input into change control activities, supporting evaluation of quality impact and compliance with internal procedures and regulatory expectations.

• Participate in internal and external audits and support inspection readiness activities.

• Support regulatory inspections by providing documentation, responding to requests, and communicating quality processes as needed.

Continuous Improvement & Expertise

• Support continuous improvement initiatives that strengthen quality systems, improve operational effectiveness, and maintain compliance.

• Apply technical knowledge and experience to identify process improvement opportunities and recommend solutions within area of responsibility.

• Maintain current knowledge of applicable regulatory requirements, GMP expectations, and industry practices.

• Mentor less experienced colleagues and share technical knowledge within the Quality organization.

• Perform additional responsibilities as required to support Quality operations and organizational priorities.

Knowledge and Qualifications

• Ability to work effectively in a team environment and collaborate across functions.

• Strong organizational and time management skills with the ability to manage multiple priorities.

• Detail-oriented with solid analytical and problem-solving capabilities.

• Effective written and verbal communication skills.

• Ability to follow established processes and apply sound judgment within defined procedures.

• Ability to assess information, identify issues, and communicate requirements clearly to appropriate stakeholders.

Job Specific Knowledge and Qualifications

• Knowledge of FDA and EU regulations and ICH guidelines applicable to cGMP drug substance and drug product manufacturing.

• Knowledge of ex-US labeling requirements is preferred.

• Hands-on experience reviewing GMP quality records (e.g., batch records, deviations, change controls, CAPAs, specifications).

• Experience supporting batch disposition activities and quality decision-making processes.

• Working knowledge of deviation investigation methodologies (e.g., 5 Whys, fishbone analysis).

• Familiarity with electronic quality management systems (eQMS).

• Ability to identify, assess, and escalate quality risks appropriately.

Requirements:

• BS/BA degree in Chemistry, Biology, or related field AND 6+ years of relevant experience with a minimum of 4 years of Quality experience within the pharmaceutical or biotechnology industry OR

• Master’s degree in life sciences or related field AND 4+ years of similar experience noted above

• Ability to work effectively in a team environment and collaborate across functions.

• Strong organizational and time management skills with the ability to manage multiple priorities

• Detail-oriented with solid analytical and problem-solving capabilities

• Effective written and verbal communication skills

• Ability to follow established processes and apply sound judgment within defined procedures

• Ability to assess information, identify issues, and communicate requirements clearly to appropriate stakeholders

• Knowledge of FDA and EU regulations and ICH guidelines applicable to cGMP drug substance and drug product manufacturing

• Hands-on experience reviewing GMP quality records (e.g., batch records, deviations, change controls, CAPAs, specifications)

• Experience supporting batch disposition activities and quality decision-making processes

• Working knowledge of deviation investigation methodologies (e.g., 5 Whys, fishbone analysis)

• Familiarity with electronic quality management systems (eQMS)

• Ability to identify, assess, and escalate quality risks appropriately

#LI-SA1

The annual base salary we reasonably expect to pay is $119,700.00-$164,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.