Overview:
The primary purpose of the position is to ensure that all products supplied to Animal Health from Asia-based Contract Manufacturers for monitoring and identification Products are manufactured, packaged, analyzed, and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.
The incumbent is accountable for ensuring that all products released for sale have been manufactured in accordance with the Product License, Product Quality Specifications, and acceptable manufacturing process practices.
The incumbent is responsible for the direct oversight of total quality performance and operations of such Third-Party Operations through direct support and technical advice, guidance, and counseling to the site Quality Operations Manager or Director, as well as on-site supervision. The incumbent exercises a leadership role in monitoring and maintaining third-party compliance with regulations and other requirements.
Responsibility:
- Reports to the Global Quality Lead Monitoring& External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Quality Lead informed on the status of operations and when challenges, opportunities and/or issues arise.
- Conducts Quality due diligence assessments, as necessary, for pre-approval considerations of new partners according to company standards for that partner
- Assures that the partner operates within the agreed upon acceptable manufacturing processes and procedures and in accordance with the Quality elements of the Commercial Agreement; ensures the Quality Agreement is kept up to date and ensures review of the Quality elements in the Commercial Agreement
- Acts as Animal Health Intelligence Quality Operations point of contact to Asia third parties and as the Quality liaison between the external partner and the internal company personnel. Coordinates Animal Health Intelligence audit plans and effective execution of subsequent remediation by the partner;
- Assures approval of the release of (initial) batches of all new products and products undergoing process changes per company standards and local regulations. Determines if additional testing is required on findings with questionable results
- Assures Quality requirements on Process Change Requests (PCRs) submitted by the partners and/or Animal Health Intelligence and conformance to all requirements on the PCR are met before approving release of batches made under the changes,
- Assures on-site guidance is provided to the partner in the preparation of Quality Systems, procedures, and guidelines as applicable; ensures robust systems for supplier and CMO management oversight exist
- Participation in the on-site demonstrations of new processes/products for assuring new product product quality, building quality plan together with the partner. and establish validation requirements to assure that the process is under control and in compliance with registered procedures. Makes on-site decisions as to the quality of the product/process and ability of site to perform quality validation and testing,
- Ensures that ongoing validation audit programs of third party operations for in-line products are implemented on a timely basis, according Animal Health Intelligence Standards and local regulations. This includes semi-annual media challenges, periodic revalidation of equipment, installation and operation qualification for new installations and product annual reviews.
- Ensures proactive support in training and coaching to initiate quality improvements within the partners Operations.
- Building quality data tools and Analyzing quality data in order to maintain and improve product and processes quality , alert to management and partner of degradation of quality levels and initiate corrective and improvement steps
Qualifications, Skills & Experience :
- Bachelor degree in electronics /mechanical /material, Chemical Engineering (or equivalent)
- Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements, at least3 years’ experience as quality engineering in PCBA/PCB manufacturing site.
- Must have excellent problem-solving skills, based on facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply risk management.
- Must have IPC610 certification.
- Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with stakeholders and internal & external customers.
- Must have expertise in electronics processes and subcontractors manufacturing, additional knowledge in plastic injection and molding will be an advantage.
- Must have strong demonstrated interpersonal, communication, negotiation, persuasion, and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity .
- Must have exemplary people/team leadership experience, including leading and motivating teams. Experienced in establishing performance metrics and holding people accountable for results.
- Must have Fluency in written and spoken English.
Critical Leadership Capabilities include
- Integrate: Ethics & Integrity
- Integrate: Courage
- Impact: Deliver Customer Value
- Impact: Make Business Decisions
- Innovate Shape Strategy