Manager

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. The position will lead a team of In-Process Quality Assurance (IPQA) team providing oversight to QA aspects of Pharmaceutical Manufacturing including but not limited to shop floor activities like line clearances, walk throughs, documentation verification, IPQA checks for manufacturing and packaging processes, AQL, BPR revision, sample management, retain samples program, visual inspection program and notification of hold for equipment, rooms, utilities etc. Additionally, person in this role is responsible QA validation team for the support of facility start-up activities, technical transfers, requalification's and routine activities validation activities as they pertain to Manufacturing, Maintenance and Warehouse functions.

JOB RESPONSIBILITIES

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
• Providing oversight to analytical labs for instrument qualifications.
• Providing training to team personnel and managing to meet goals established
• 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.

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.
• This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.

Other requirements (licenses, certifications, specialized training)

• Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE), ASQ is preferred