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.

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%.

Full timeRegularColleague

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.

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.

Originally posted on Himalayas