Manager- Quality Assurance Regulatory Affairs Mississauga, ON

• Canada
• Mississauga
• Posted 2 years ago

Globyz
Position Description

To be the part of management, this position must play a leadership role and provide technical expertise related to the overall Quality and regulatory requirements of drug products. Reporting to CEO, you will be responsible for directing and managing the staff of Quality, Regulatory and Operations departments at Globyz Pharma. The focus will be on creating and implementing the high level of GMP compliance for the maintenance of Drug product quality during storage and transportation. The successful candidate will also establish effective documentation systems and efficient processes as per Health Canada regulatory requirements that will allow timely release storage and distribution of drug products. In addition, deliver training to staff at Globyz Pharma where applicable and provide technical support to investigate deviations. This position will be responsible for renewal of DEL, handling regulatory and customer audits, product recalls, and maintaining, establishing and sustaining a continuous improvement culture in quality and operation with the support of senior management.

Responsibilities

• Provide technical support to Quality, RA and Operation Departments.
• Create, review, approve and implement Standard Operating Procedures (SOP) for all GMP activities at Globyz Pharma from receiving, inspection, storage, shipping of drug products as well for the maintenance and control of storage facility.
• Provide leadership role in handling the Quality systems; deviation, change controls and customer complaints, Recalls.
• Coordinate, improve and sustain the activities and cooperation in the Quality/Operation departments and with all other departments at Globyz Pharma.
• Provide hands on coaching to Quality and Operation teams.
• Liaison with Health Canada, Regulatory agencies, customers, suppliers, partners and other Globyz Pharma departments.
• Provide support to the senior managements and administration from a Quality and Operation aspects, when required.
• Maintain and improve quality systems at Globyz Pharma, with reliable processes that promote quality and efficiency to critical cycles.

Critical Competencies

• Profound and insightful knowledge in Pharmaceutical Quality Assurance, Quality Control, Regulatory Compliance, Distribution Operation and Regulatory Licensing requirements.
• Hands on experience in handling of deviation, CAPA, change controls and customer complaints / product Recalls are must.
• Knowledge in handling drug products, Pharma validation, regulatory affairs and technical / product development from a quality perspective would be an asset.
• Knowledge and experience in processes and continuous improvements.
• Strong interpersonal and communication skills (written and oral).
• Solid experience in Quality and in managing and sustaining efficient quality systems.
• Customer orientation (internal and external) with a commitment to taking the initiative and making positive change in the area.
• High proficiency with MS Office applications (Excel, Word, Power Point), email and software. Active listener and willing to work as a team or lead a team and ensure that team members are contributing.

Decision Making Authority

• Product disposition, to release or reject products.
• Leading investigations with a focus on problem solving to prevent future occurrences and to ensure the release of quality product by Globyz Pharma for customer use.
• Provide support and ability to audit partners and customers. Identify the gaps and non-conformances against current regulations.
• Use of validation knowledge to evaluate and review and approve validation protocols and reports (facility, equipment, product shipping studies) and capable of selecting appropriate validation activities to be performed.
• Hiring and performance evaluation of quality and operation staff.

Education And Experience

• University Degree in Sciences (Biology, Chemistry) from a Canadian university or equivalent. Advanced degree an asset.
• Minimum of 5 years of diversified experience in the pharmaceutical industry, including quality assurance, Quality Control, production, Validation and Compliance.
• Solid knowledge of Canadian and US FDA GMPs and quality requirements for drug products.
• Minimum of 2 years in a leadership role managing people and teams.
• Experience Leading customer audits and regulatory inspections
• Hand on experience for continuous improvement in processes (Packaging/ Labelling and Distribution systems).

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