About this role
<p style="text-align:justify"> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Your Magic with us! <span style="color:#ffffff">Start your next chapter and join MilliporeSigma.</span></span></span></p> <p> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. </span></span></p> <p> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. </span></span></p> <p> </p><p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Your Role:</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Lead the governance of the SQM system to ensure compliance with cGxP regulations, applicable ICH and ISO guidelines/standards, and Merck and LS standards and procedures</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Serve as a technical authority in drug regulations and industry standards specifically related to supplier quality to ensure consistency in interpretation of cGxPs throughout the business</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Develop and execute strategic plans to improve supplier quality and costs on a global basis</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Identify strategic initiatives to drive continuous improvement opportunities within the SQM system and harmonize procedures across sites globally to enhance efficiency</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Leverage close collaboration across different geographies (US, EU, UK, APAC) and proactively seek support from key stakeholders to obtain the required input and alignment with Quality strategies</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Create, manage, and drive effective plans to improve the culture of quality with defined actions, timelines, and KPI reporting to BioReliance CTS leadership, Quality and site leadership, or other Merck stakeholders as required</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Manage supplier quality resources in the areas of strategic sourcing, new product development, and at key suppliers ensuring the assessment, qualification, and approval process for suppliers are based on risk, QMS capabilities, and technical competence</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Provide oversight for supplier qualification activities including scheduling, planning, and conduct of supplier audits and participate in development and negotiation of Quality Agreements</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Manage supplier nonconformance, investigations, and corrective actions and preventive actions (CAPA) to resolve quality issues</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Evaluate supplier-initiated change notifications and conduct risk assessments for materials and services</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Participate in site readiness activities and provide SQM support in managing client audits, internal audits, and regulatory inspections</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Financial Dimension</span></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Manage resource and financial planning to ensure alignment with business needs and quality requirements.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Management of People</span></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Actively manage the performance and development of teams using available tools and procedures, ensuring all team members have appropriate goals and objectives set.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif"> </span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Who You Are</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Minimum Qualifications:</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Bachelor’s degree in a scientific discipline; advanced degree preferred</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Quality certification in auditing or a Quality related discipline</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">8+ years working in a cGMP/GLP environment/FDA/EMA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">5+ years of leadership in Quality Assurance in Bio/Pharmaceutical or Life Sciences industry</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change. Previous experience in a client facing Quality role is preferred</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Working knowledge of 21 CFR 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Expertise in managing and leading the transformation of SQM or other quality systems</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Experience with regulated products or services across different geographies preferred</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Experience as a SQM subject matter expert and/or as a host during regulatory inspections and as a certified lead auditor for customer or client audits</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Preferred Qualifications:</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Fluent in both written and spoken English</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Excellent leadership & management skills</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Excellent communication, interpersonal & conflict resolution skills</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Leadership experience in building and/or enhancing an SQM system</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Direct experience in communicating with regulatory authorities preferred</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Experience of managing a global operation preferred</span></li> </ul> <p style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p>Pay Range for this position: $133,900-$220,900</p> <p> </p> <p>The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click <a target="_blank">here</a>.</p><p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>What we offer:</strong> We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!</span></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</span></span></p>