Contractor Quality Lead
Role Description
1. Job Title
- Manager, Contractor Quality Lead (CQL)
2. Role Purpose
- Acts as the virtual internal Quality representative for Contract Manufacturing Organizations (CMOs).
- Ensures external partners meet Zoetis Quality Standards and comply with GMP and regulatory requirements.
- Provides Quality oversight for assigned CMOs, with guidance from the Team Leader as needed.
- Ensures CMOs maintain robust and effective Quality systems.
- Evaluates Quality-related investigations and supports continuous improvement initiatives.
- Acts as a liaison between Zoetis and CMOs for:
- Audits
- Quality Agreements
- Deviations
- Changes
- Complaints
- Regulatory commitments
- Identifies and mitigates Quality and compliance risks.
- Participates in cross-functional Quality projects.
- Works collaboratively, seeks guidance when needed, and ensures externally manufactured Zoetis products are safe, effective, and compliant.
3. Supervisor / Reports To
- Global External Manufacturing Quality Operations Team Leader
4. Core Competencies
Technical Knowledge & Operational Excellence
- Manages assigned CMOs, with Team Leader support when required.
- Ensures key Quality activities are monitored and followed up.
- Demonstrates working knowledge of:
- Manufacturing processes
- Validation
- Test methods
- Regulatory requirements
- Seeks guidance where technical knowledge is limited.
- Tracks, monitors, and analyzes CMO Quality activities using designated tools.
- Ensures commitments and actions are completed on time.
- Assesses CMO investigations to confirm:
- Appropriate root cause identification.
- Effective CAPA implementation.
Accountable for Results
- Takes responsibility for actions and results.
- Plans and organizes work effectively.
- Aligns priorities with business goals and deadlines.
- Remains focused and productive under pressure.
- Sets appropriate priorities and completes commitments on time.
- Holds CMOs accountable for delivering agreed commitments.
Strategic Thinking & Initiative
- Demonstrates initiative, independence, and a proactive mindset.
- Advocates for and implements change aligned with business and Quality objectives.
- Promotes continuous improvement, simplification, and innovation.
- Applies lessons learned to improve outcomes.
- Suggests and supports cost-effectiveness and Quality improvement initiatives at CMOs.
Problem Solving & Decision Making
- Proactively addresses Quality issues before they escalate.
- Makes timely, data-driven decisions using experience and sound judgment.
- Makes decisions even when information is incomplete.
- Determines appropriate escalation based on risk and impact.
- Engages and influences appropriate stakeholders.
- Handles unexpected situations with agility and resilience.
- Takes appropriate action to mitigate Quality and compliance risks.
Communication & Collaboration
- Communicates clearly, concisely, and effectively.
- Tailors communication to the target audience.
- Builds and maintains collaborative partnerships within Zoetis and with CMOs.
- Communicates effectively across all organizational levels.
- Provides executive summaries and proactive updates.
- Seeks feedback and learns from mistakes.
- Prioritizes team success over individual accomplishments.
5. Key Responsibilities
Quality Agreements
- Negotiates terms of the Quality Agreement template.
- Ensures implementation of the agreement is approved before commercial batch production.
- Independently evaluates changes to the standard template.
- Identifies items requiring escalation or additional endorsement.
- Periodically reviews Quality Agreements to ensure continued compliance.
Change Management
- Independently assesses product-related change proposals from a Quality perspective.
- Coordinates regulatory assessments with the Regulatory team.
- Processes acceptable changes.
- Manages implementation timelines at the contractor.
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