Department: LS-AS-TQ Global Quality Recruiter: Leah S Westley
This information is for internals only. Please do not share outside of the organization.
Candidates can located in Rockville, MD or Glasgow, UK
Your Role:
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
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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
Candidates can located in Rockville, MD or Glasgow, UK
Financial Dimension
Manage resource and financial planning to ensure alignment with business needs and quality requirements.
Management of People
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.
Minimum Qualifications:
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
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
Pay Range for this position: $133,900-$220,900
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 here.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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