POSITION SUMMARY
The QC Manager will report to the Site QC Lead and be responsible to supervise and lead the Laboratory release function including Raw Materials, Intermediates, DPI and API's (including the stability program) and In Process Control and provide core technical support in areas of chromatography, investigations/deviations, troubleshooting, instrument calibration/qualification, and regulatory requirements. The QC Manager will provide a strong degree of technical and compliance leadership within the QC function as well as driving Quality System improvements and operational efficiencies within the lab and representing the Quality Department at meetings both on and offsite. The QC Manager will also be involved in the training, coaching and development of QC Analysts and have input to performance review and assessment.
POSITION RESPONSIBILITIES
Key objectives of this position include:
1. Leading the QC Area in the Laboratory, providing direction, leadership and support.
2. Laboratory investigations / deviations Chromatography & general Analytical troubleshooting.
3. Laboratory Documentation review (including documentation RFT improvement).
4. Planning and Scheduling of Laboratory Testing Activities, Equipment qualification / calibration oversight.
5. Ensuring Compliance of Laboratory Systems with current regulatory requirements.
6. Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples Collection,
7. Review and Approval of Data for CPV and APR's Continuous improvement / operational excellence activities including Laboratory 5S and Lean Labs program.
8. Method transfers and validation activities.
9. Leading the Laboratory Tier 1 / visual management system meetings.
10. Ensuring that the laboratory is operated in a continuous compliant manner & all processes and procedures are followed.
11. Driving Quality System improvements within the QC laboratories.
12. Ownership of Laboratory Systems as assigned.
13. Review and approval (as applicable) ensuring the accuracy, completeness and compliance of: Analytical and associated data generated within the laboratory; procedures (e.g. SOP's, EOP's, Training modules etc.) and Master Analytical Records; compendial changes; analytical change Authorization packages; static data on ZLIMS; Safe Work permits etc.
14. Coach and mentor QC Analysts within their team, supporting their training and development.
15. Support the development of Quality goals and targets as part of the organisation's strategic plan/roadmap.
16. Support development of Quality Operations Budget including resource planning and ensure adherence to Laboratory Budget.
17. Serve as a Quality Culture role model and instill a strong Quality and Compliance Culture within the QC Team.
18. Works with internal and external colleagues and ability to collaborate effectively with others.
19. Drives for Superior Results and Passion to Win with demonstrated record in getting things done.
20. Sets Clear Direction and Aligns Team and Others Around Common Objectives
21. Demonstrates capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives.
22. All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.
23 All employees are expected to model inclusion behaviours. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.
24. Will contribute to the overall performance of Zoetis and the achievement of the Company's strategic objectives through daily exhibition of Zoetis Core Beliefs and leading by example within the site Quality Team.
SYSTEM OWNER / SUBSYSTEM OWNER RESPONSIBILITIES
System Owner (SO) System Owners have overall accountability for the site Quality Systems for which they are responsible and in particular for:
* Providing strategic & proactive direction with respect to the System (across the site) in terms of content and execution.
* Providing support, guidance & coaching to Sub System Owners (SSO).
* Ensuring that SSO regularly review sub-systems for their effectiveness, escalating issues where required to site Quality Council (QRC) for action & remediation.
* Owning relevant System issues in the site Compliance Plan.
* Defining resources as needed & communicating resource needs to Site Lead.
* Applying people change control across Sub-Systems within their responsibility.
* Ensuring that SSO have proactive continuous improvement plans for their SubSystems.
Sub System Owner (SSO) Sub-System Owners have overall accountability for the site Quality Sub-Systems for which they are responsible and in particular for:
* Providing strategic & proactive direction with respect to their Sub-System (across the site) in terms of content and execution.
* Regularly reviewing their Sub-System & presenting Sub-System review to Quality Council (QRC) as required. Escalating issues where required to the System Owner (SO) and site QRC for action and remediation.
* Owning relevant Sub-System issues in the site Compliance Plan.
* Defining resources as needed & communicating resource needs to SO.
* Developing & implementing proactive continuous improvement plans for their subsystem.
* In partnership with the SO, ensuring that there are clearly defined expert(s) for each sub-system, acting as a point of contact during inspections.
* Overseeing all documents associated with their sub-system and providing input to the document owners during updates.
* Providing comments on new/revised draft policies and guidelines and completing impact assessments where required.
ORGANIZATIONAL RELATIONSHIPS
This position directly reports to the Site Quality Control Lead.
Interact regularly with site Leadership, Global Manufacturing and Technology (GMT), and Operations to ensure site goals and objectives are met. T
his position will need to achieve results through collaborating with colleagues directly or indirectly including;
* Quality Team - both QA and QC
* Manufacturing operations leads and team.
* GMT on and offsite
* Operational excellence team
* Regulatory affairs offsite
* GMP inspection /corporate inspection
EDUCATION AND EXPERIENCE
* Bachelor of Science in Chemistry with 5-10 years of proven quality control and analytical laboratory experience with at least 2 years supervisory experience preferred, and with a demonstrated track record in the management of a modern analytical / microbiology laboratory operating in a GMP environment.
* Familiarity with specialized areas such as analytical instrumentation, automated laboratory systems, validation, and current regulatory expectations.
* Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) preferred.
* Experience with water system validation, environmental monitoring standards and process validation.
TECHNICAL SKILLS AND COMPETENCIES REQUIRED
Ability to provide strong technical and people-based leadership and to work effectively in a team environment with ability to develop and adhere to self-directed standard work.
* Excellent written and communication skills, as well as experience with presenting to leadership teams.
* In depth knowledge of procedures and work practices relevant to the operation of a Laboratory and associated IT Tools.
* Knowledge of regulatory standards (both existing and emerging) relevant to the laboratory.
* Experienced in Lean Lab /continuous improvement projects.
* Experienced with Problem solving Techniques (e.g., RCI/FMEA)
PHYSICAL POSITION REQUIREMENTS
This is Rathdrum, Ireland Site based position.
* This position requires onsite presence to supervise a 24/7 operational laboratory therefore while occasional remote working may be possible, primarily this is a site-based position
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
Global Job Applicant Privacy Notice