Quality Assurance Validation Manager
|Monroe, North Carolina - United States
$85,000.00 - $120,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Assurance Validation Manager to join our growing team. The Quality Assurance Validation Manager is responsible for providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance. This position will be responsible for ensuring successful implementation of validation standards as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, person in this role is responsible for the support of facility start-up activities, technical transfers, re-qualifications and routine activities as they pertain to Laboratories, Manufacturing, Maintenance and Warehouse functions.
Responsibilities include but are not limited to:
- Manage within approved budgets while building best in class quality processes and systems at site.
- Take appropriate steps to reduce waste and loss by improving efficiency
- Manage the validation system from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives
- Act as the quality / validation SME for Change Controls supporting GMP/GLP systems.
- Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.
- Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.
- Ensure Site Validation Master Plan is followed at site level.
- Quality oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.
- Quality oversight and approval of internal and external process characterization project plans, protocols and report.
- Report validation/qualification quality issues and trends to management.
- Provide leadership and guidance to staff on qualification/validation issues.
- Review and revise SOPs for consistency and compliance with regulatory requirements
- Support regulatory inspections by FDA and foreign regulatory agencies
- Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.
- Participates in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
- Leads standardization and harmonization of Standard Operating Procedures.
- Partner with R&D and Tech Transfer groups to develop and execute product technical transfer plans to the Manufacturing facility
- Provide support to the initiation, assessment and implementation of internal change controls
- Apply risk based methodologies in the oversight of validation efforts.
- Manage the Change Control Systems supporting GxP Systems.
- Participate in cross-functional risk assessments and process parameter classification
- Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports
- Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities
- Ensure compliance with current U.S. and EU cGMP regulations and industry standards
- Participate on interdepartmental project / program teams to meet company / site milestones and objectives
- Provide expertise to technical teams in the implementation of strategies for characterization and validation studies
- Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction
- A minimum of a Bachelor’s degree in Science or Engineering or associated fields is required.
- A minimum of ten (10) years 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.
Knowledge & Skills:
- Extensive knowledge of quality tools:
- Validations and Qualifications
- Regulatory guidelines
- US Pharmacopoeias
- Internal auditing
- Handling of regulatory Inspections
- Well acquainted with QMS
- 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.
- Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired
- 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
- Will be an added advantage if the individual has dealt with multiple audits personally.
University - Bachelor's Degree/3-4 Year Degree