Senior Manager, Quality

• Maintain compliance with ISO 9001 and applicable quality requirements across all aspects of the Quality Management System including internal and external audits CAPA nonconforming material management validation activities and document control.
• Lead mentor and develop direct reports fostering a high-performing team culture built on accountability collaboration and continuous learning.
• Drive quality excellence initiatives that strengthen quality culture improve organizational effectiveness and support long-term business objectives.
• Partner with site leadership and global quality stakeholders to support the continued development and implementation of enterprise-wide quality management processes.
• Develop monitor analyze and communicate quality metrics and KPIs to assess organizational quality health identify trends and drive data-based decision making.
• Lead or support internal and external audit programs ensuring timely execution effective root cause analysis and completion of corrective and preventive actions.
• 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.

• Bachelors 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 $135000-$190000. Compensation decisions are dependent on several factors including but not limited to an individuals 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 BehaviorsIntegrity & Compliance Customer Focus Collaboration Courage Team Empowerment and Accountability & Resultsin all aspects of work.