Oversee document control processes and ensure quality procedures, policies, and records remain compliant, effective, and current.
Provide quality oversight for investigations, deviations, nonconforming materials, out-of-specification results, and CAPA activities, ensuring appropriate risk assessment and resolution.
Identify and implement continuous improvement opportunities that increase efficiency, strengthen compliance, and enhance overall quality system effectiveness.
Champion strategic quality projects, including digital transformation initiatives such as the transition from paper-based quality documentation and certificates to electronic quality systems.
Collaborate effectively with cross-functional teams to support product release activities, operational priorities, and broader business initiatives.
Utilize risk-based decision making to maintain compliance while enabling business success.
Qualifications
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
Minimum of 10 years of experience within an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
Minimum of 4 years of people leadership experience, including coaching, mentoring, and developing direct reports.
Demonstrated expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
Strong knowledge of Good Documentation Practices (GDP), root cause analysis methodologies, and quality investigation processes.
Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement.
Proven ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
Strong organizational, problem-solving, and project management skills, with the ability to balance strategic priorities and day-to-day execution.
Experience leading quality system improvements, transformation initiatives, or digitalization projects preferred.
Lean, continuous improvement, or operational excellence experience preferred.
Excellent communication, collaboration, and relationship-building skills.
Demonstrated commitment to fostering a positive quality culture and developing high-performing teams.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $135,000-$190,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
