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• Review quality records related to GMP products manufactured by Contract Manufacturing Organizations (CMO) for compliance to CGMPs

• Perform timely disposition of GMP products in accordance with applicable regulations and internal procedures

• Participate in project teams, serving as the QA representative and escalate issues to senior QA management when appropriate

• Independently provide Quality support for new product introduction (NPI) processes for new products and/or for substantial changes to existing products (e.g., new CMO, scale-up, process validation)

• Interface with internal and external stakeholders to process quality records and resolve issues

• Lead and/or participate in deviation investigation teams

• Participate in the change control process for changes related to clinical and/or commercial products

• May participate in or conduct audits of external suppliers

• May participate in compliance inspections and inspection readiness activities

• Support and interact with other Quality functional areas to ensure compliance with internal processes and procedures and to promote continuous improvement

• Other duties as assigned

• BS/BA degree in Life Sciences, Engineering, or related fieldand4+ years of experience in quality within the pharmaceutical or biotechnology industry OR Master27s degree in Life Sciences, Engineering, or related fieldand2 years of similar experience as noted above

• Works well in a team environment

• Ability to work closely with both internal and external personnel

• Strong organizational and time management skills

• Ability to meet multiple deadlines with a high degree of accuracy and efficiency

• Attention to detail, critical thinker and effective organizational skills

• Strong verbal and written communication skills

• Ability to quickly assess new information and communicate requirements to the appropriate individuals

• Basic knowledge of FDA and EU regulations and ICH Guidelines and their applicability to CGMP drug substance and drug product manufacturing

• Hands-on experience reviewing quality records related to GMP manufacturing (e.g., batch records, labeling, deviation reports, specifications, change controls, CAPAs)

• Ability to identify and escalate problems and follow-through with corrective actions

• Experience with investigation methodologies (e.g., fishbone diagrams, 5 Whys, pareto charts)

• Experience with electronic quality management systems

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The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. 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 20% 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.