QC Manager

POSITION SUMMARY

Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 3-5 concise sentences. It may be helpful to complete this section after you have finished the other sections of the document.

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.

Their role is to 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.

They will also be involved in the training, coaching and development of QC Analysts and have input to performance review and assessment.

POSITION RESPONSIBILITIES

By use of bullet points and in order of importance, list the primary responsibilities critical to the performance of the position. For Staff positions, focus on essential responsibilities that highlight accountability and level of judgment required.

Key objectives of this position include:

Leading their Functional Area in the Laboratory, providing direction, Leadership and Support in the following activities.

Laboratory investigations / deviations Chromatography & general Analytical troubleshooting Laboratory Documentation review (including documentation RFT improvement), Planning and Scheduling of Laboratory Testing Activities, Equipment qualification / calibration oversight, Ensuring Compliance of Laboratory Systems with current regulatory requirements Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples Collection, Review and Approval of Data for CPV and APR's Continuous improvement / operational excellence activities including Laboratory 5S and Lean Labs program Method transfers and validation activities Leading the Laboratory Tier 1 / visual management system meetings. Ensuring that the laboratory is operated in a continuous compliant manner & all processes and procedures are followed. Driving Quality System improvements within the QC laboratories Ownership of Laboratory Systems as assigned 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. Coach and mentor QC Analysts within their team, supporting their training and development Support the development of Quality goals and targets as part of the organisation's strategic plan/roadmap. Support development of Quality Operations Budget including resource planning and ensure adherence to Laboratory Budget. Serve as a Quality Culture role model and instill a strong Quality and Compliance Culture within the QC Team.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

This 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

The successful candidate will need to interact regularly with site Leadership, Global Manufacturing and Technology (GMT), and Operations to ensure site goals and objectives are met.

All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.

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.

EDUCATION AND EXPERIENCE

Indicate the formal education, certification or license required and/or preferred. Include the minimum number of years of relevant experience required for the position.

• 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.

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

Indicate the technical skills required and/or preferred, as applicable.

Include skills and knowledge essential to perform the position.

• 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..
• Flexible, adaptable and receptive to new and innovative ideas.
• Sets Clear Direction and Aligns Team and Others Around Common Objectives
• In depth knowledge of regulatory standards (both existing and emerging) relevant to the laboratory.
• In depth knowledge of procedures and work practices relevant to the operation of a Laboratory and associated IT Tools.
• Experience with water system validation, environmental monitoring standards and process validation.
• Demonstrated problem-solving skills.
• Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives
• Drives for Superior Results and Passion to Win with demonstrated record in getting things done.
• Demonstrated ability to work with internal and external colleagues and ability to collaborate effectively with others.

PHYSICAL POSITION REQUIREMENTS

Note the physical conditions in which work will be performed, if applicable to the position. Examples: ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.

• 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.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.