Quality Assurance Manager

6 days ago

Bloomington, Indiana, United States Glenmark Pharmaceuticals USA Full time
Job Title: Manager, QA Validation

Glenmark Pharmaceuticals USA is a leading player in the discovery of new molecules, with a strong presence in the US generics market. We are seeking a highly skilled Manager, QA Validation to join our team.

Job Summary:

The Manager, QA Validation will be responsible for providing leadership and strategic direction to the establishment of validation/qualification programs, ensuring alignment with corporate standards and regulatory guidance. This role will involve ensuring successful implementation of validation standards as they apply to facilities, utilities, equipment, computer systems, cleaning, and processes.

Key Responsibilities:
  • Preparation of revenue and capex budget, ensuring financial prudence in resource planning and allocation.
  • Maintenance of quality system controls to ensure no critical and major market complaints.
  • Reduction of wastages and losses in the analysis process and improvement of efficiency.
  • Management of the validation system from a Quality Assurance perspective, ensuring quality and compliance requirements are met in an efficient and effective manner.
  • Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports, and associated change control systems.
  • Ensuring site validation master plan and CSVMP are followed at site level.
  • Quality oversight and approval of internal and external process characterization project plans, protocols, and reports.
  • Reporting of validation/qualification quality issues and trends to management.
  • Providing leadership and guidance to staff on qualification/validation issues.
  • Review of executed calibrations and preventive maintenance (PM) plans, as well as review of calibration/PM program updates.
  • Review and revision of SOPs for consistency and compliance with regulatory requirements.
  • Providing oversight to analytical labs for instrument qualifications.
  • Providing training to team personnel and managing to meet goals established.
  • Support of regulatory inspections by FDA and foreign regulatory agencies.
  • Participation in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit, and stakeholder feedback, and corrective/preventative actions.
  • Participation in cross-functional risk assessments and process parameter classification.
  • Providing hands-on review and subject matter expertise of Validation lifecycle documentation, including Process Design Documents, Process Control Strategy, Master Plans, Protocols, and Reports.
  • Providing quality oversight and support for process, cleaning, shipping, computer system, equipment, and instrument qualification and validation activities.
  • Participation on interdepartmental project/program teams to meet company/site milestones and objectives.
  • Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.
  • Application of risk-based methodologies in the oversight of validation efforts and CSV activities.
Requirements:
  • A minimum of a Bachelor's degree in Science or Engineering or associated fields is required.
  • A 6-10 years of experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing.
  • Advanced degrees may be used to reduce required experience.
  • Extensive knowledge of quality tools: CGMP, Validations and Qualifications, Regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, Well acquainted with QMS and CSV, Well versed with Change control/deviations and market compliant management system.
  • Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures.
  • Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required. Strong documentation skills are required.
  • Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis are also desired.
  • The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
  • This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.
  • Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired.

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