Define and implement quality management standards and processes within the CM Biotech team (SOP system, training, Compliance Management System, Change Management, deviations, CAPA etc) and assures compliance through self-inspections and internal audits. Supports supplier audits. Responsible for KPI and monthly reports to senior leadership.
Define and approve all contracts manufacturing quality related activities, processes and structures throughout the global product supply networks of Biotech products with non-PS Biotech sites and external production sites; align QA activities globally within PS Biotech and with Contract Manufacturers; evaluates and approves product changes using Change Management tools; works with contract manufacturers to ensure manufacturing deviations are investigated, root cause analysis is complete and CAPAs are closed in a timely manner for all products within PS BT contract manufacturing.
Establish, implement and verify QA standards for all Biotech products sourced from contract manufacturing partners; determine disposition of deviations and complaints in line with and PS Biotech quality standards; represent Contract Manufacturing QA on the Global Quality Leadership Team
Provide quality requirements and standards to all Operations Teams and product development teams, represent voice of Quality and Compliance in all product and process related decisions to assure quality and compliance for PS Biotech Contract Manufacturing.
Lead and organize assessments of current Biotech product licenses and implements the TRD system for all Biotech products; review and approve all regulatory submissions to improve and assure regulatory compliance.
Leads global interdisciplinary project teams with representatives from the manufacturing sites and external suppliers to define, modify and improves Quality Testing and Quality Assurance of CM Biotech products; coordinate and approve all QC testing method transfers to production sites and sales organizations world-wide.
Oversee external audits (regulatory authorities & customer audits) for Biotech products at internal and external production sites, escorting auditors; initiate and lead supplier audits for raw materials, intermediates and medical devices.
Provide effective leadership to CM Biotech Quality Function including: development and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with Performance Calibration/Talent Pool Management/Succession Planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in management of their employees/department which support achievement of individual/department/business objectives
May represent QA Biotech in due diligences; negotiate QA agreements with external suppliers and resolve disputes.
PhD in (Bio) Chemistry, Pharmacy, Biotechnology or similar education Minimum experience: 10+ years of leadership experience in a Quality environment in manufacturing or development of pharmaceutical or biotech products 7 years' experience in international biopharmaceutical / pharmaceutical industry…or an equivalent combination of education and experience
Excellent knowledge of Quality Management processes Excellent knowledge of biopharmaceutical manufacturing/CMC Excellent knowledge of EMA and FDA requirements in cGMP Excellent understanding of manufacturing process technology in the Biotech area Good project management skills, experienced in working with international, interdisciplinary teams (internal and external matrix organizations) Significant experience managing and providing oversight to Contract Manufacturers who supply product intermediates and/or finished goods Strong interpersonal skills, leadership and motivation of employees Ability to lead organizational change and build teams Strong analytical and conceptual thinking, target oriented Strong decision making skills Strong quality and cost awareness, negotiation skills Willing to travel as required Excellent knowledge of English language, negotiation level
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
LinkedIn Search: Sam Caley Quality Assurance
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