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.
• Escalates significant topics to management of both companies when required.

Deviation Management

• Independently evaluates the impact of significant CMO deviations.
• Determines appropriate actions and escalation levels.
• Engages relevant organizations based on risk and impact.
• Ensures appropriate follow-up and resolution.

CAPA

• Provides robust oversight of CMO CAPAs.
• Tracks CAPA progress.
• Holds contractors accountable for timely and effective closure.
• Verifies CAPA effectiveness through data review and follow-up.
• Escalates delays and systemic issues.
• Supports compliance and continuous improvement.

Product Disposition & Batch Release

• Applies the lot disposition process for Zoetis products released to Zoetis by the contractor.
• Performs annual risk assessments to determine the applicable lot disposition process.

Complaints Management

• Works with the Pharmacovigilance team on external market complaints.
• Ensures complaints are investigated thoroughly and within required timelines.
• Monitors complaint trends.
• Proactively addresses recurring issues with CMOs.
• Supports continuous improvement and customer experience.
• Determines escalation levels for critical complaints and complaint trends.

Materials Management

• Acts as the Quality Single Point of Contact for Zoetis-tolled materials.
• Manages Quality-related activities involving suppliers, including:
  • Quality audits
  • Complaints
  • Deviations
  • Regulatory-required information

Annual Product Reviews / Minor Change & Stability Reports

• Ensures timely receipt of Annual Product Reviews (APRs) from contractors.
• Thoroughly reviews and endorses APRs.
• Ensures required corrective and preventive actions are defined and implemented.
• Ensures stability data and other required information are provided to Regulatory on time.
• Supports Minor Change and Stability Report (MCSR) submissions.

Auditing

• Assesses the need for routine CMO audits.
• Coordinates and facilitates audit activities.
• Participates in CMO audits.
• Independently performs audits when qualified under the Zoetis Auditor Certification Program.

Regulatory Activities

• Maintains a high-level understanding of applicable regulations.
• Ensures regulatory expectations are met.
• Works effectively with Regulatory Affairs colleagues across required markets.
• Independently supports accuracy and compliance of regulatory submissions.

BoH Inspections

• Monitors upcoming inspections and inspection results.
• Determines whether CMO CAPA responses are appropriate.
• Communicates inspection outcomes and relevant actions to stakeholders in a timely manner.

Artwork

• Reviews draft artwork.
• Verifies accuracy of critical elements according to applicable procedures.

Digital Systems & Documentation

• Applies standard work practices.
• Ensures timely and accurate entry of CMO-related activities into designated digital systems, including:
  • Veeva Vault
  • CMO Tool
  • TrackWise
• Ensures documentation complies with procedural requirements.

Stability

• Ensures annual stability commitments are completed on time.
• Ensures Out-of-Specification (OOS) results are appropriately escalated through the RNR process.
• Proactively assesses the effectiveness and applicability of the stability program.
• Supports temperature excursion assessments.
• Provides stability memos or impact evaluations to support:
  • Product quality
  • Product safety
  • Product efficacy
  • Lot disposition decisions

Other Responsibilities

• Supports enhancement of the Zoetis Global External Manufacturing Quality System.
• Revises procedures where required.
• Leads cross-functional Quality improvement initiatives.
• Shares best practices.
• Benchmarks practices across regions.
• Collaborates with colleagues to optimize systems.
• Drives continuous improvement.

6. Qualifications, Experience & Profile

Education

• Bachelor’s or Master’s degree in:
  • Pharmaceutical Science
  • Microbiology
  • Chemistry
  • Equivalent scientific discipline

Experience

• Significant experience in a regulated industry.
• Relevant experience in areas such as:
  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Auditing
  • Technical functions, such as Engineering or R&D
  • Regulatory Affairs

Languages

• Fluent in English.
• Fluent in the local language.
• Knowledge of additional regional languages is desirable.

Product & Regulatory Knowledge

• Knowledge of a broad range of products.
• Understanding of global regulatory requirements.
• Experience across a diverse product portfolio is preferred.
• Animal Health industry experience is ideally preferred.

Travel

• Willingness to travel up to 20%.