Your Role:
This position is primarily responsible for establishing and managing the Bioindustry Quality System with respect to leading strategic quality initiatives that strengthen compliance, drive risk-based auditing, and enhance supplier quality oversight across a global network of sites and suppliers.
Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability.
Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
Provide leadership, mentorship and oversight to the Audit and Supplier Quality function and develop people and teams.
This role will influence GMP manufacturing activities and enterprise-wide quality strategy, improve inspection readiness, and proactively identify and mitigating risks that impact product quality and patient safety. Success in this role will be measured by the effectiveness of audit and supplier quality programs, regulatory compliance, risk reduction, and the development of a high-performing team that support operational excellence.
Essential Duties & Responsibilities:
- Participate in a lead role in internal, external and regulatory authority audits, including the timely preparation of audit reports and responses to audit findings. Coordinates and hosts client and regulatory authority inspections, as required. This includes audit strategy, prioritization, planning, execution, reporting, and governance.
- Prepare/assess quality audit findings with respect to required corrective actions and ensures timely reporting to QA leadership and conducts follow-up.
- Monitor audit results, compliance trends, quality risks, and inspection outcomes to identify systemic issues and inform risk-based quality decisions. Communicate quality program performance, risks, and key priorities to senior leadership.
- Oversee the audit team, including auditor qualification, development, and program effectiveness.
- Lead and collaborate with site and functional leaders to support inspection readiness, remediation activities, and ongoing compliance improvement efforts.
- Lead the Quality Agreement program.
- Establish goals for the Supplier Quality department according to the global and site strategy and take action to ensure timely delivery of goals.
- Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
- Oversee maintenance of the Approved Supplier List (ASL)
- Lead supplier risk management activities to mitigate supplier impact to Lentigen (audit failures, refusal to comply with qualification requirements, introduction of excipients in technical transfer projects)
- Program manage improvement projects to streamline existing cross functional workflows for reduction of errors and time to completion. This includes New Supplier Requests (NSR), supplier-related Deviation investigations, Supplier Notifications (SNC)/ Supplier Alerts
- Lead and develop teams while balancing quality, compliance, and operational priorities across multiple programs and functions.
- Manage the day-to-day activities to include writing, review and approval of Standard Operating Procedures and business practices.
- Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
- Perform Quality Assurance review of regulatory submission documents in support of submissions to regulatory authorities, as required.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, or a related technical field; 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience.
- Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred.
- Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred.
- Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives.
- Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs.
- Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness.
- Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results.
- An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas.
- Excellent oral and written communication.
- Excellent organization skills allowing the coordination of multi-faceted QA activities
- Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products
Skills:
- Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.
The hiring range for this position is expected to fall between $110,026 - $129,413/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.
In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.
Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.
