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:
A leadership role responsible for designing, implementing, maintaining, and improving the Quality Management System (QMS) to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable International Council for Harmonization (ICH) and International Organization for Standardization (ISO) guidelines/standards, other global regulatory requirements as outlined in the BioReliance Testing Services Global Quality Manual, and Merck and Life Science standards and procedure. Responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities. Directs the resolution of highly complex or unusual operational problems applying advanced analytical thought.
Lead the governance of core quality systems to ensure they are compliant with cGxP regulations, applicable ICH and ISO guidelines, and Merck and LS standards and procedures
Drive continuous improvement of quality systems and harmonize procedures across global sites 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
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Ensure the review and approval of quality system records including deviations, investigations of Out of Specification (OOS) and anomalous results, CAPA, etc.
Ensure the robust conduct of investigations to identify root causes and drive continuous improvement across the organization
Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
Participate in site readiness activities and provide Quality Systems 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
Provides leadership and direction through supervisors/managers
Minimum Qualifications:
Bachelor’s degree in a scientific discipline; advanced degree preferred
Certification in Lean Six Sigma and a Quality related area is beneficial
10+ years working in a cGMP/GLP environment FDA/EMA or equivalent regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution
8+ years of leadership experience 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 11, 58, 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 quality systems such as investigations of nonconformances including deviations and out of specification investigations, corrective actions and preventive actions (CAPA), effectiveness checks, management control, internal audits, and change controls
Experience with regulated products or services across different geographies preferred
Mastery in hosting regulatory inspections and managing responses
Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
Leadership experience in building and/or enhancing quality systems such as investigations, change controls, etc.
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: $154,700-$290,300
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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