Manager, Depot and Production
Parexel International Corporation
São Paulo, São Paulo, Brazil
The Manager Depot and Production will be accountable for leading the respective Depot team to perform any type of production according to current Good Manufacturing Practice (cGMP). This includes the maintenance of the facility, equipment in use, training of the personal as well as the identification of process improvement opportunities.Manager Depot and Production ensures compliance with applicable current Good Distribution Practice (cGDP) with employment legislation, company policies and procedures relating to employees, relevant company SOPs, regulatory guidelines, and departmental written procedures. This role operates within the departmental budget and in accordance with departmental goals and objectives. Regulatory requirement for this position to be Licensed under Federal - ANVISA and State SIVISA - laws of Brazil to operate the Brazil Depot.
- Team Leadership.
- Recruit, retain and develop a team of skilled, experienced, and motivated staff.
- Ensure direct reports meet and aim to exceed their personal goals and objectives by developing appropriate orientation, performance review and development plans for all direct reports.
- Support and improve levels of productivity/billability through effective task-allocation, staff assignment and defining roles & responsibilities.
- Enable- a high performance culture through a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the staff in an open, balanced, and respectful manner.
- Complete the formal performance and salary review processes to corporate standards.
- Drive business and projects growth; increasing revenues and profits.
- Help to implement a lean management approach and process improvements, in line with corporate, quality, client and team feedback and quality audits.
- Strong customer focus.
- Contribute to projects, committees and task force groups as needed.
- Review TIME entries and TIME reports and provide accurate input into monthly reports.
- Provide team consultation, facilitate appropriate metrics collection, and develop action plans.
- Promote new business by participating in internal PAREXEL meetings and work streams, project/program bids and client presentations as appropriate.
- Monitor and support the current Good Manufacturing Practices (cGMPs), current Good Distribution Practices (cGDPs) and European Union (EU) standards for the local operation and for global harmonization internally.
- Maintain the facility according cGMP requirements and monitors compliance continuously.
- Responsible for performing thorough evaluations of deviation and establishing Corrective and Preventive Action (CAPA).
- Ensure that training is performed and recorded in time.
- Guarantee that production activities are accurately described in written procedures and that these procedures meet cGMP requirements, including the review and approval of batch production documentation.
- Safeguards that appropriate documents are in place for distribution of clinical materials
Knowledge and Experience:
- In-depth knowledge of clinical trial supply, ancillary and/or clinical laboratory market.
- Good understanding of the regulatory drug development and logistics framework.
- Financial knowledge and profitability mind-set (e.g. KPI measurement, Budgeting & Forecasting).
- System knowledge in supply chain enterprise solutions.
- Relevant direct pharmaceutical industry experience in Clinical Trial Supply, Ancillary Supply or Central Laboratory Services.
- Leadership experience in a high growth global service environment.
- Building and retaining client relationships in the biopharmaceutical industry.
- Involvement in change projects.
- Customer Focus Leadership Managing Operations cGXP Expertise
- Educated to BA / BS degree (logistics, pharmacy, biological science or other health related discipline or MBA preferred).
- Excellent English skills.
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