Job Description

States considered:

Role

The Quality Control Manager will have responsibility to manage, lead and direct a team of QC staff. The Quality Control Manager will have overall responsibility to manage, coordinate and oversee all QC activities in accordance with site objectives, quality standards and global Zoetis policies, as well as with all relevant regulatory and legislative regulations. Direct, coordinate and oversee all analytical activities including in-process, release and stability testing of drug substance and drug product materials, as appropriate. QC release of raw materials and Microbiology testing to support manufacturing schedule. The QC manager will provide a Leadership role in maintaining the Quality Systems within the Laboratory; ensuring that Standard Operating Procedures are in compliance with cGMP is adhered to at all times. Support method transfer and validation of bioanalytical methods where required. The role is also responsible for the initiation, coordination and management of stability studies from registration through to commercialisation. Oversee and coordinate outsourced testing at third party contract laboratories

Duties & responsibilities:

• Responsible for the day to day management and leadership of the QC function & QC teams

• Responsible for the department personnel management; and directly participating in department personnel recruitment, performance management and training.

• Direct and oversee analytical services performed at Tullamore Site and third party contract laboratories

• Budget holder - responsible for resource loading of all projects, developing the op-ex and capex budget requirements and annual strategy plans and monthly reporting of forecast versus actual send

• Support analytical methods transfer and validation in conjunction with GMT Analytical group to ensure methods are adequately developed, validated, transferred and maintained

• Ensure that testing is performed in an efficient, compliant and timely manner and is assessed against applicable specifications

• Provide analytical support with data compilation and review in support of regulatory dossier submissions Ensure laboratory investigations and non conformances are thoroughly investigated and resolved against required timeframes using DMAIC approach

• Continuously review quality control processes, procedures and capabilities in order to sustain the most cost-effective processes

• Ensure adequate and timely qualification and testing of raw material components and timely QC release of raw materials to support manufacturing schedule.

• Ensure environmental monitoring & microbiological testing programs are maintained in support of ongoing batch manufacturing

• Complete performance reviews for direct reports and support the development of goals, career plans and targets in line with overall site objectives

• Assume a lead role in audit preparation ensuring the QC function is audit ready

• Work closely with specialist contract testing service providers to ensure execution of all deliverables for all outsourced testing programs

• Oversee and approve technical reports on completion of transfer validation and technical studies

• Ensure good project management & planning skills to enable coordination, management & resource planning for various project activities

• Drive continuous improvement initiatives which positively impact testing cycle time, productivity, efficiency and quality of work through lean methodology and OpEx tools

• Understand and Drive QC Lab Capacity Utilization analysis and resource planning

• Approve specifications, sampling instructions, test methods, and other quality control procedures, ensuring their implementation.

Organisational Relationships

Directly reports to the Site Head of Quality.

• Strong working relationship with all QC colleagues, Production, QA, GMT, Supply chain, warehouse, and project personnel.

• Develop and/or maintain strong working relationships with relevant third party vendors, global supply, other QC departments within the network

Resources Managed

Financial Accountability Accountable for Quality Control Budget including continuous monitoring to ensure adherence to the QC site budget.

Supervision QC lead positions and support personnel as required.

Education & Experience

• BSC in a relevant discipline (e.g. biochemistry, chemistry) or equivalent experience.

• Proven ability to manage and supervise work in a laboratory with a minimum of 5 -10 years management experience

Technical Skill Requirements

• Strong background in biopharmaceutical testing including QC release testing, validation methodology transfers and stability studies

• Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, HPLC, Capillary Electrophoresis, potency methods.

• Good knowledge of regulatory guidelines relating to Quality Control, stability testing and method validation.

• Good knowledge of release testing, specification setting and stability study requirements

• Knowledge & familiarity of relevant sections of regulatory dossiers.

• Knowledge of analytical methods required to support process characterisation, validation & technical studies

• Knowledge of Equipment Qualification requirements with experience dealing with suppliers of analytical equipment and materials.

• Management of CMO / CRO activities

Physical Position Requirements

Role is based at Tullamore, Ireland

Full time

Legal statement as below

This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.

Visa status re must be eligible to work and live in Ireland as below

Colleague must be legally eligible to live and work in Ireland.

of our Benefits

In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.