External Supply Quality Manager
Posted on Sep 11, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Zurich we are looking for External Supply Quality Manager for 12 months project.
Job Title: External Supply Quality Manager
Duration: ASAP to 16/08/2021
This position has responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule Contract Manufacturing Organisations (CMOs), Suppliers, and Contract Testing Laboratories (CTLs) located within the European region, inclusive of Drug Product, QC testing, packaging, and labelling activities.
The External Supply Quality Manager is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the Oncology & External Supply Small Molecule (OncESSM) Operating Unit, and other External Supply regions, with manufacturing sites, Local Operating Companies (LOCs), and external partners.
. Responsible for the product quality performance at designated CMOs/Suppliers, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with relevant standards/cGMP and Global Quality Standards.
. Responsible for the preparation, approval and maintenance of Quality Agreements with relevant CMOs/Suppliers.
. Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, Key Performance Indicators (KPI) and other Quality processes and tools as required.
. Support and champion the implementation of compliance strategies, quality plans and Quality Assurance programmes for the management of outsourced product manufacturing/packaging operations to assure the quality and compliance and partner products.
. Represent to make decisions on acceptability of quality programmes and ongoing activities at the CMO/Supplier.
. Responsible for complying with the requirements of the Quality Incident Management process for relevant CMO/Supplier manufactured products. Prepares and issues notifications and prepares for Quality Alignment Meetings in collaboration with the ESQL and/or Site Quality Head, and other stakeholders.
. Establish quality and compliance expectations for CMOs/Suppliers and support as needed CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with relevant standards/cGMP and Quality System expectations.
. As necessary work with specific LOCs to assure compliance with country-specific requirements/regulations for the manufacturing/packaging of product for represented markets.
. Support and/or lead audits of CMOs/Suppliers and CTLs, including preparation of audit reports and review of the acceptability of CMO/CTL corrective actions.
. Provide oversight in the assessment of changes or deviations for products, to assure compliance to market/regulatory commitments, assessment and evaluation of risks, support appropriate disposition of product, and correction or improvement of operations to minimise future risks.
. Maintain awareness of relevant legislation and regulatory guidelines, and assure that QA supplier management programmes, systems and controls, are reviewed and updated as needed to assure compliance. As necessary, confirm requirements and regulations of other markets in support of manufacturing, testing and packaging activities.
. Support successful and timely completion of all product submissions, launches and new initiatives as well as at contract manufacturing, packaging and labelling operations.
. Assist with audits and inspections of Oncology & External Supply Small Molecule, other facilities, and third-party suppliers associated with commercial product supply. May represent during regulatory inspections, as needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
. Minimum of Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 5 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
. Experience of cGMPs, ICH and other pertinent regulations.
. Project Management expertise desired.
. Familiar with Common Technical Documents (registration files).
. Skills required:
§ Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
§ Analytical Skills - ability to thoughtfully analyse a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
§ Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management.
§ Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
§ Regulatory understanding - broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing and packaging.
§ Fluent in written and spoken English.
. Critical Thinking.
. Current on local and global regulations.
. Digital and analytical skills.
. Investigation and problem solving.
. Good communication skills engaging stakeholders: site, business, network, company, regulators, etc.
. Risk identification, evaluation and management.
. Continuous improvement.
. Familiar with negotiation/influence.
. Works independently and assertively.
. Enterprise thinking - finding innovative ways to serve patients build reputation and trust.
. Focus on the few priorities and provide superior results.
. Elevate capabilities for now and the future.
. International travel as needed to support the business (up to approximately 30%).