Reporting to the Director of Quality Affairs, the AssociateDirector of Quality Affairs is responsible for ensuring products are manufactured, inspected, tested, and packaged according to GMP and Company requirements. This is done on a day-to-day basis by providing leadership and direction to drive manufacturing operations and suppliers towards higher quality products and processes in accordance with corporate strategy, cGMP, and regulatory compliance. This includes developing strategic business plans and the tactical actions and resources necessary to execute them. The Assistant Director will be responsible for managing operational budgets including leading continuous improvement initiatives in quality. This position manages the performance of 3 direct reports: Quality Control Manager, QA Manager, Compliance and Microbiology Manager
Key Role Specific Requirements
- Provides leadership 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.
- Provides leadership for developing, directing and conducting training initiatives for all employees.
- Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Monitors QA systems (example: Out of Specification investigations, Non-Compliance investigations) and advises management team on system performance; publishes KPIs regarding performance against set goals and makes recommendations.
- Assists 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.
- 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.
- 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.
- Participates in hosting facility audits by customers, FDA and Health Canada including responding to corrective actions and /or observations as required.
- Act on behalf of the Director of QA in all duties in their absence.
- Bachelor’s degree in the life sciences.
- 7 years’ relevant experience in a regulated pharmaceutical industry including Quality Assurance, Quality Control, and Quality Systems
- 5 years in a leadership role, either as a direct manager/leader and a project lead for an enterprise-wide project with cross-functional team
- Advanced knowledge and application of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, within a manufacturing and packaging environment.
- Must possess expected leader competence to effectively and efficiently collaborate and communicate with all levels internally and externally. In particular with off-sight leadership within the North American region and externally with regulatory agencies, vendors and customers as required.
- Displayed ability to step up and address difficult issues, saying what needs to be said in a manner that is supportive to our core values.
- Has built strong-identity teams that apply their diverse shills and perspectives to achieve common goals.
- Can operate and lead effectively, even when things are not certain, or the way forward is not clear.
- English, strong communication skills, both written and verbal.
- MS degree or MBA
- Direct experience with representing a company during a regulatory inspection, either as the site principal Quality person, and/or subject matter expert.
- Can readily apply and leverage knowledge of business and the marketplace to advance the organization’s goals
- LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.
- EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
- CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.
- ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
- STRATEGIC THINKING – The ability to analyze the company’s competitive position by considering market and industry trends, existing and potential customers (internal and external), and strengths and weaknesses as compared to competitors.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.