Department: Azzur Solutions, LLC
This includes developing strategic business plans and the tactical actions and resources necessary to execute them. The Manager will be responsible for managing operational budgets including leading continuous improvement initiatives in quality.
Key Role Specific Requirements
Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
· Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (eg Continuous Improvement) and supporting new product development.
· Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
· Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
· Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
· Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
· Acts as the primary contact with regulatory agencies for all communication for the site.
· Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
· Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
· Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
· Responsible for final product release to customer.
· Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
· Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
· Organizes and hosts facility audits by customers, FDA and Health Canada including responding to corrective actions and /or observations as required.
Competencies Required for the Role
Please include no more than 5 competencies most applicable to this role from the list provided. Include the definitions provided as well.
- COGNITIVE FLEXIBILITY – Is the ability to switch from one behavior to another depending on requirements, and reflect on several options to solve problems quickly.
- COMPLEXITY/STRESS MANAGEMENT /TIME MANAGEMENT-The ability to keep functioning effectively when under pressure and maintain self-control.
- CUSTOMER ORIENTATION – The ability to demonstrate concern for satisfying one’s external or internal customers. Identifies and prioritizes customer needs and recognizes constraints. Seeks to find out more about customers and provide better service. Is professional, reliable and delivers on promises. Brings a competitive focus to customer.
- DELEGATION – is the assignment of authority to another person to carry out specific activities. It is the process of distributing and entrusting work to another person. It is not only giving the responsibility to do the work but the authority to do the work. It is one of the core concepts of management leadership. The ability to convey confidence in employee’s ability to be successful.
- INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
- What does the word ‘integrity’ mean to you?
- 8 years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, with 3 years in a leadership role
- BSc degree in science or related field
- Knowledge of Analytical Chemistry, Microbiology, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, aseptic manufacturing and packaging processes
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
- MS degree or MBA as asset
Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender, and age in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.