Title: Quality Assurance (QA) Manager, Contract Manufacturing Organisations (CMOs)

Vacancy Type: Full Time, Permanent: Biotechnology

Salary & Benefits: Highly Competitive

Location: Hybrid

Vacancy Reference: 24035

Vacancy Key Responsibilities:
• Key performance indicator (KPI) development/tracking and operational deliverables are taken into account as part of the process of qualifying suppliers
• Organisational strategy and business realities are taken into account while formulating and enforcing CMO compliance rules and processes such as Quality Agreements, Quality Business Processes, Product Disposition and Deviations, and Corrective Actions
• Establishes and maintains quality management systems that meet internal and regulatory requirements, as well as quality standards
• Consistent and collaborative messaging to external manufacturing/testing partners must be achieved by participation in company’s External Manufacturing team, Virtual Plant, and Analytical Teams
• Provide... internal teams and external manufacturing partners with a single point of contact for QA technical support through cross-functional work
• Clearly conveys problems, threats, and solutions to colleagues within the company
• Evaluates batch records and authorises vector release
• Performs Quality Assurance reviews and approvals of pertinent GMP documents, including but not limited to: deviations, OOS, investigations, CAPAs, revisions, validation documentation, and more
• Acts as a conduit for information between the QA CMO team and the manufacturing partners
• Acts as a Quality Assurance specialist on Cell Bank, Plasmid, and Vector manufacturing teams
• Assists with audits (both internal and external) and related paperwork (PLI/PAI) as required
• Helps CMOs get ready for inspections
• Maintain key performance indicators, metrics, and other CMO enhancement projects
• Possibility of up to 35% travel (both domestically and abroad)

Vacancy Key Requirements:
• The minimum requirement is a bachelor’s degree or the equivalent in biology, biochemistry, cell biology, microbiology, chemistry, engineering, or a related field
• You need to have managed external suppliers and dealt with supply chain challenges before
• Six or more years of experience in the field, including at least five years of QA/QC/compliance experience
• Excellent planning and time management skills, with a track record of seeing projects through to fruition
• Expertise in managing and leading teams, persuading others, negotiating, and working with suppliers
• The freedom to act unilaterally, with a keen eye for the long-term consequences of their choices
• Fluency in both oral and written English
• Proven ability to lead by example and guide less experienced colleagues
• Proven skill in thriving in a matrixed work environment
• Expertise in current laws and guidelines pertaining to Cell Therapy supplies
• Competence in overseeing audits and inspections
• Possess the organisational skills necessary to handle multiple, conflicting projects at once
• Meticulous; capable of analysing complex situations and coming to sound conclusions
• Work experience in Biotechnology or Biopharmaceutical
• Knowledge of gene-based products, cell-based therapeutics, and/or biologics
• Proven track record in product launch, tech transfer, and/or PLI/PAI
• Proficient in managing post-approval changes and the production and distribution of commercial products
• Expertise in process mapping, root cause analysis, and problem definition, among other advanced project management techniques
• Proven success working in a matrixed, high-pressure setting

Vacancy Reference: 24035 (Must Include Vacancy Reference When Applying).

Although the position is in Groningen, Netherlands we advise you to apply from other parts of EU or European Non-EU countries, Pharmakia is updated with similar vacancies across Europe on daily basis
Groningen Netherlands

Salary Criteria