Manager -IPQA /QA Validation
Position Summary
The Manager, IPQA/QA-Validation is responsible for providing leadership and strategic direction to the In Process Quality Assurance (IPQA) team and validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance.
Responsibilities
Results Expected/Target Financial Support in Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and management within approved budgets while building best in class quality processes and systems at the site
Operational Excellence Responsible for overall management of IPQA/QA-Validation activities Manage the validation system from a Quality Assurance perspective
Oversee sampling process for in-process, finished product, stability, and retention samples for the development, commercial, and validation batches
Act as the IPQA /Validation SME for Change Controls and Investigations supporting GMP/GLP systems.
Ensure required Standard Operating Procedures and systems are implemented to support manufacturing and validation programs.
Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.
Report validation/qualification quality issues and trends to management.
Provide leadership and guidance to staff on qualification/validation aspects.
Review and revise SOPs for consistency and compliance with regulatory requirements.
Provide leadership, mentoring, and development opportunities for the staff.
Maintain visual inspection qualification program including AQL for the products
Stakeholder Support regulatory inspections by FDA and foreign regulatory agencies
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.
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
Ensure GMP compliance at the shop floor as per respective SOP
Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities
Participate on interdepartmental project / program teams to meet company / site milestones and objectives
Innovation 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
Ensure compliance with current U.S. and EU cGMP regulations and industry standards
Apply risk based methodologies in the oversight of validation efforts and CSV activities
Knowledge, Skills And Abilities
Education (degree / diploma) A minimum of a Bachelor’s degree in Pharmaceutical Science or Engineering associated fields is required
Experience 6-8 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
Knowledge and Skills (Functional / Technical) 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
Literacy / Communication Skills Excellent written and oral communication and interpersonal relationship skills
Leadership / Managerial Attributes The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required
Other Requirements (licenses, Certifications, Specialized Training) Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE), ASQ is preferred