Quality Operations Sr. Manager

Summary of the Position 

Responsible for product quality, regulatory compliance, quality systems, and processes at the Campinas site. Accountable for all aspects related to Quality according to Brazilian and international Good Manufacturing Practices (GMP) and other applicable standards and regulations, as well as Zoetis Global Quality Standards. Responsible for compliance with regulatory requirements, including global regulatory requirements, global quality policies, company policies, procedures, and other applicable guidelines. This position reports to the Quality Lead - Pharma Americas with interface to the Site Leader. 

Main Responsibilities 

• Drive the establishment of quality systems and culture to create lasting regulatory compliance and provide guidance and leadership to other site managers to enhance compliance with GMP systems. 

• Maintain site compliance through continuous improvement processes focused on technology, people, and/or processes. 

• Supervise the design and implementation of information systems for data storage and retrieval. 

• Review, identify, and manage changes in technology, people, and processes to increase efficiency and compliance, ensuring regulatory and company policy requirements are met. 

• Coordinate operations of the Quality Assurance, Compliance, Validation and Quality Control departments. 

• Approve or reject all incoming production materials, in-process products, and finished products to ensure compliance with company, industry, and government policies. 

• Make final decisions and provide advice in resolving production process issues, in-process products, final product release, and product complaints to ensure timely resolution. 

• Establish and maintain programs for product development, including sampling materials and products for testing, monitoring filling and labeling activities, and stability testing. 

• Maintain adequate laboratory facilities for biological, serological, chemical, and physical testing of marketed and developing products for release and/or stability evaluation, components, and control of aseptic production facilities. 

Additional Responsibilities 

• Manage Quality Systems including audits and follow-up on corrective/preventive actions, production deviations, and atypical events related to customer complaints, change control, and all out-of-specification (OOS) or atypical analytical results, according to Brazilian or other applicable GMPs. 

• Review and investigate (when necessary) all quality complaints from internal and external customers. 

• Ensure compliance with GMP and Zoetis quality procedures across all departments. 

• Approve the Validation Master Plan and verify execution of validation protocols and reports for new and existing facilities. 

• Coordinate the review of Batch Records for marketing authorization requirements. 

• Prepare, evaluate, and approve all GMP documentation including Site Master File, procedures, record sheets, various data collection methods by QA, Production, Engineering, and Maintenance, etc. 

• Review local production and filling operations according to Good Production Practices. 

• Coordinate documentation control to ensure availability, use, and periodic updating of Standard Operating Procedures (SOPs) for all relevant production and quality processes. 

• Manage issuance of printed components, including labels and seals for production, and compliance with established requirements. 

• Train colleagues in GMP and manage all training information in the appropriate database. 

Regulatory and Team Management 

• Coordinate supplier qualification according to Zoetis operational procedures. 

• Manage release for marketing of finished products, including preparation of Certificates of Analysis and export-related documents. 

• Coordinate all regulatory activities at the plant, acting as the link to the Global Regulatory group, with direct relations to local regulatory authorities and inspections by external authorities. 

• Contribute to process improvement efforts, quality enhancement, and cost reduction. 

• Report to the Quality Lead – Pharma Americas Platform any occurrences outside normal standards, for corrective measures as necessary, following Escalation to Management Process. 

• Ensure quality and robustness of processes through continuous improvement plans. 

• Identify and develop people/talents, motivate and engage the team in meeting continuous improvement goals, according to company values. 

• Comply and ensure compliance with legal and regulatory requirements regarding EHS - Environment, Health, and Safety, such as use of PPE, medical exams, and others, according to SOPs. 

• Encourage the team’s participation in EHS trainings, events, and campaigns. 

• Encourage reporting of risk situations to the EHS area, using the Good Catch program. 

• Prevent unsafe acts at work, preparing operational procedures, including risk observations and prevention methods, involving EHS if necessary. 

• Ensure good condition of equipment in the area of responsibility. 

• Promote order, cleanliness, and ensure workplace safety in responsible areas through use of 5S methodology. 

• Ensure confidentiality of information under responsibility. 

• Comply and ensure compliance with the companys Code of Conduct. 

• Manage related activities of the team under responsibility. 

Managed Resources 

Financial Responsibility: Annual budget for the Quality Operations department 

Supervision: Direct Reports-1 QA Manager and 1 QC Manager (Organization with around 60 colleagues) 

Education and Experience 

• Bachelor’s degree in pharmacy, biology, chemistry, or related fields. 

• Thorough knowledge of GMP, regulations for biological and pharmaceutical products, company policies related to employees, accounting, SOPs, and safety regulations. 

• Senior Manager with extensive and solid experience in pharmaceutical and biological Quality Assurance and people management. 

• Fluent written and spoken English. 

Required Technical Skills 

• Experience managing regulatory requirements and audits. 

• Knowledge of Quality Control testing and manufacturing processes performed by the company. 

• Knowledge of Engineering and Maintenance processes performed by the company. 

• Knowledge of Supply Chain, Logistics/Storage processes performed by the company. 

• Solid experience in a manufacturing environment. 

• Experience in establishing and managing business objectives and achieving superior results. 

• Effective business management experience focused on results. 

• Excellent oral and written communication. 

• Skills in conflict management and time management. 

Full time