Associate Director of Quality & Compliance (Florida) at APOTEX

About Apotex Inc.Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.For more information visit:.Job Summary Reporting to Senior Director Global Quality Services the Associate Director Quality & Compliance at the Apotex Corp office is responsible to provide Quality & Compliance oversight of cGMP and Drug Enforcement Administration (DEA) related activities for all Apotex United States Operations.The Associate Director Quality & Operations is accountable for all Quality & Compliance related activities/decision making and provide strategic leadership to the functional areas within Apotex United States Operations.This role would also be part of site leadership team at both Indianapolis Distribution Center and Apotex Corp office and is responsible for audit readiness of Apotex United States Operations.Responsible for overseeing Customer Complaints by triaging and working with the manufacturing sites to investigate and provide customers with the outcome of the complaints.Job Responsibilities Overall responsible for Quality activities which support regulatory compliance and business requirements at Apotex United States Operations:Provide visible results oriented leadership that supports Apotexs Mission Core Values and strategic plan.Lead and role model the Quality Culture mindset.Implement internal quality procedures ensuring adherence to Global Quality Policies Standards Operating Procedures and GMPs.Establish and maintain Quality performance metrics that support the Apotex United States Operations quality goals.Be an active member of the Global Quality Compliance Management team and support all Quality & Compliance enhancement initiatives.Represent Apotex position and policy during regulatory/customer audits in relation to material/product disposition and quality investigations.Participate actively in Quality forums and drive actions as needed to remediate compliance risks.Support best practice sharing harmonization standardization and continuous improvement of quality mind set across the Apotex organization.Responsible for compliance to DEA regulations on the storage and distribution of controlled substances.Responsible for managing the team that receives the customer complaints timely follow up with the respective manufacturing sites complaint sample returns follow ups and complaint resolution. This position encompasses a much broader understanding of TrackWise and SAP systems for all aspects of and Quality Complaints.Responsible for maintaining relevant Quality & Compliance related procedures updates GMP training of all Apotex United States Operations.Oversight of Investigations Management ensuring all Apotex United States Operations quality investigations are handled in a compliant and efficient manner. Ensure product status and dispositions related to investigations are made visible and support business needs while maintaining compliance.Accountable for overall Product Disposition activities and documentation which support the business and GMP compliance needs of finished product distribution across United States. Responsible for providing senior quality leadership support for logistics distribution and warehouse activities at the Indianapolis Distribution Centre.For all People Leaders:Participate and lead performance conversations with employees including monthly one on ones to connect on performance; check in on employees progress toward achieving Objectives offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.Utilize open honest two way communication to build trust-based relationships with employees business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our Winning Behaviours Individual Accountability Rigor & Discipline and Continuous Improvement.Utilize your networks to attract and hire talent in a comprehensive differentiated and consistent manner essential to our continued growth; then onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.All other duties as assigned.Job Requirements Education: Bachelor of Science DegreeKnowledge Skills and Abilities:Strong understanding of GMP requirements and their application in a manufacturing and distribution environmentKnowledge of international GMP requirementsStrong organizational interpersonal and communication skillsExhibited business acumen in understanding cross-functional processes requirements and relevant information flows and translating gaps into solutionsDemonstrated strategic process-driven analytical and critical thinkingProven experiences in holding people accountable developing cross-functional teams and facilitating decision-making processesProven ability to lead manage and motivate subordinatesDemonstrated interpersonal savvy and relationship management/networking skillsStrong ability to deal with ambiguity and manage through difficult situationsProven ability to manage multiple complex projects at the same timeExcellent ability to delegate and affect change through others without direct involvementExercise innovative tactics and encourage others to demonstrateStrong written and oral communication skillsExperience:Minimum 10 years of quality assurance experience in the pharmaceutical industry7-10 years of leadership experience preferably in a quality assurance roleExperience in Pharmaceutical Manufacturing operations and controls change management processes regulatory affairs validation leadership influencing and negotiationAt Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.Required Experience:Director Key Skills Crisis Management,Marketing,Public Relations,Fundraising,Media Relations,Constant Contact,Strategic Planning,Social Media Management,Team Management,Public Speaking,Wordpress,Writing Skills Employment Type : Full Time Experience: years Vacancy: 1 Yearly Salary Salary: 7 - 10