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On behalf of our client from pharmaceutical industry, we're looking for Senior Quality Manager to be based in Basel.
The Senior Quality Manager is part of the Supplier Relationship Team (SRT) and is the primary point of contact of the quality oversight with assigned Contract Manufacturers (CM) and Logistics Providers (3PLs) to ensure for the Company's products a high level of quality, trust and reputation towards customers and regulators.
Key responsibilities
* Ensure the products manufactured on behalf of the Company by the CM will follow the the Company's Quality Management System with vigor and the cGMP as well, defined and monitored by key performance and quality indicators.
* Accountable for establishing and maintaining a strong and effective working relationship to ensure quality requirements are met by the key contacts at each of the assigned CMs, Logistics Providers (3PLs), internal stakeholders and SRT members (example of partnership with Supply Chain, Technical, Procurement, Regulatory, Logistics, Affiliate or Distributor QA, and other stakeholders / experts within the Company). Ensure relevant functions/organizations are informed as appropriate of any topic which may have business and/or supply impact.
* E2E management of daily operations within the assigned portfolio including deviation management (including OOS/OOT/OOE), change controls, CAPAs, expedite complaints, stability program, review, and approval of technical documentation (i.e., validation, transfer), Quality Improvement, documentation approvals (Specs & Masters), registration related requests, QRI/QAlerts, PPRs. Escalate all serious cGMP/Regulatory compliance issues.
* Act as PIRC Secretary for Product Incident and Review Committees (PIRCs) by helping the PIRC Chair managing inputs (investigation, risk assessment, SME advice) and outputs (product hold and/or market action decisions). Act as PIRC Chair in-training, when required.
* Apply appropriate Risk Management tools with each CM & Logistic provider in scope, escalating and tracking significant risks requiring resolution, including complaint monitoring and trending, reporting to Quality Council, Product Incident Review Committee (PIRC) or other Corporate Governance processes, as required.
* Lead Quality Agreement negotiations with CMs, Logistic providers, affiliates &/or distributors. Evaluate effectiveness of the CM Quality Unit and systems. Promote robust systems under self-sufficient organizations. Monitor and assess External Suppliers’ key performance indicators, such as complaints and Right First Time as a mechanism to propose Continuous Improvement initiatives.
* Support and lead internal audit processes where required. Work with CM to establish sustainable CAPA. Ensure timely and appropriate closure of CAPA at assigned CM. Review and respond to CM regulatory inspections on matters that involve activities related to products. Assess impact of inspection and CM responses to Regulatory observations prior to submission to the associated agency.
* Support new product introductions, including the implementation of development quality agreements, from an operational perspective. Eventually review and approve significant documentation associated with the introduction or transfer of a new or existing product to CM.
* Perform activities related to Medical Devices including batch verification as per Delegation received from Legal Manufacturer PRRC in compliance with EN ISO 13485:2016 including the requirements of the Medical Device Directive 93/42/EEC as amended and Regulation (EU) 2017/745 and UK MDR 2002 as amended andtheprocedures, if applicable.
Key requirements:
* 8 years’ experience in various Technical and Quality Assurance roles.
* Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
* Previous assignment experience promoting or requiring global perspective desirable.
* Project Management skills and leadership skills
* Operational Excellence exposure.
* Demonstrated ability to be assertive.
* Demonstrated sense of urgency, to complete the investigations including all necessary information to make decisions on batch disposal.
* Breadth in Quality Systems principles and practical application.
* Good knowledge and demonstrated application of Quality and Risk Management principles and tools.
* Demonstrated sound decision-making process; based on facts & data, and application of Risk Management principles.
* Technical knowledge of multiple dosage forms.
* Demonstrated ability to effectively prioritize work.
* Demonstrated ability to excel at execution. Analytical and conceptual thinking required. Effective and sustainable solutions should be provided.
* Excellent verbal and written communication skills with strong presentation skills.
* Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
* Strong problem-solving skills, with a disposition for continuous improvement.
* Demonstrated ability to work and collaborate in cross-functional teams.
* Demonstrated intercultural skills. Capability to work with diverse and widespread team.
* Demonstrated commercial acumen to effectively work with external companies
* Ability to adapt, anticipate issues, work under uncertainty, and accommodate flexible work demands.
* Capable of working independently
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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