Head of Supplier Quality Management

Merck Group • $133K — $220K *
Rockville, MD 20850In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline; advanced degree preferred
  • Quality certification in auditing or related discipline
  • 8+ years in a cGMP/GLP regulated industry with a strong quality improvement track record
  • 5+ years of leadership in Quality Assurance in the Bio/Pharmaceutical industry
  • Knowledge of various compliance regulations including FDA and EMA standards
  • Experience as a SQM subject matter expert during regulatory inspections

Responsibilities

  • Lead governance of the SQM system for compliance with cGxP regulations
  • Serve as a technical authority on supplier quality regulations and standards
  • Develop and implement strategic plans to enhance global supplier quality
  • Identify and drive continuous improvement in SQM procedures
  • Collaborate with stakeholders globally to align Quality strategies
  • Manage supplier quality resources and ensure rigorous supplier qualification processes
  • Oversee supplier audits and manage nonconformance and CAPA efforts

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Performance-based bonuses
Full Job Description
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
  • 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


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.


Who You Are

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


Preferred Qualifications:
  • 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


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.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

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SEARCH MERCK GROUP JOBS

READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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