Manager -IPQA /QA Validation

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

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

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

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

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

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.