Head of Supplier Quality Management

Merck•Rockville, MD

12d•Hybrid

About The Position

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. 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. Develop and execute strategic plans to improve supplier quality and costs on a global basis. Identify strategic initiatives to drive continuous improvement opportunities within the SQM system and harmonize procedures across sites globally to enhance efficiency. 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. Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed. 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. 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. Provide oversight for supplier qualification activities including scheduling, planning, and conduct of supplier audits and participate in development and negotiation of Quality Agreements. Manage supplier nonconformance, investigations, and corrective actions and preventive actions (CAPA) to resolve quality issues. Evaluate supplier-initiated change notifications and conduct risk assessments for materials and services. Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization. Participate in site readiness activities and provide SQM support in managing client audits, internal audits, and regulatory inspections. Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate. Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones. Manage resource and financial planning to ensure alignment with business needs and quality requirements. Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements. Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation. Actively manage the performance and development of teams using available tools and procedures, ensuring all team members have appropriate goals and objectives set.

Requirements

Bachelor’s degree in a scientific discipline; advanced degree preferred
Quality certification in auditing or a Quality related discipline
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
5+ years of leadership in Quality Assurance in Bio/Pharmaceutical or Life Sciences industry
Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change
Previous experience in a client facing Quality role is preferred
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
Expertise in managing and leading the transformation of SQM or other quality systems
Experience with regulated products or services across different geographies preferred
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

Nice To Haves

Fluent in both written and spoken English
Excellent leadership & management skills
Excellent communication, interpersonal & conflict resolution skills
Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
Leadership experience in building and/or enhancing an SQM system
Direct experience in communicating with regulatory authorities preferred
Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills
Experience of managing a global operation preferred

Responsibilities

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
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
Develop and execute strategic plans to improve supplier quality and costs on a global basis
Identify strategic initiatives to drive continuous improvement opportunities within the SQM system and harmonize procedures across sites globally to enhance efficiency
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
Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed
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
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
Provide oversight for supplier qualification activities including scheduling, planning, and conduct of supplier audits and participate in development and negotiation of Quality Agreements
Manage supplier nonconformance, investigations, and corrective actions and preventive actions (CAPA) to resolve quality issues
Evaluate supplier-initiated change notifications and conduct risk assessments for materials and services
Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
Participate in site readiness activities and provide SQM support in managing client audits, internal audits, and regulatory inspections
Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate
Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones
Manage resource and financial planning to ensure alignment with business needs and quality requirements
Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements
Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation
Actively manage the performance and development of teams using available tools and procedures, ensuring all team members have appropriate goals and objectives set