Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more – Medisca delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.
The Quality Manager ensures compliance with all applicable regulations, industry standards, and internal quality processes in the pharmaceutical manufacturing environment. This position involves leading quality team members, driving continuous improvement initiatives, and maintaining the highest standards of product safety, efficacy and reliability.
Annual Salary: minimum 95K
Responsibilities & Duties:
Inspections
Primary host for internal, customer and regulatory inspections. Liaison for federal and state agencies. Responsible for hosting all inspections. Provide updates and inspection details to senior management. Develop plans and actions for any noted violations and deficiencies. Ensure effectiveness checks for all corrective actions are completed.Oversee the Quality Team
Assign duties to quality team to ensure compliance with procedures and regulations. Ensure quality team supports site operations as required. Ensure all quality processes are followed according to policies and procedures and timelines are respected.Current Good Manufacturing Practice (cGMP) Regulations
Ensure Adherence to cGMP regulations. Ensure policies and procedures align to Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and cGMP regulations. Designated representative for state board of pharmacy licensing. Review and approval of Standard Operating Procedures (SoPs).Controlled Substances
Ensure company policies and procedures adhere to all applicable controlled substances regulations. Act as employee Power of attorney for site. Responsible for the review and approval of suspicious orders.Quality Events
Responsible for the approval of deviations, Non Conforming Material Requests (NCMRs), customer complaints, Corrective and Preventive Actions (CAPAs), Supplier Corrective Action Requests (SCARs). Responsible for the approval of customer complaint letters. Establish necessary corrective and preventive actions related to all quality events. Monitor and analyze quality performance metrics and present findings to senior management. Facility Management and Support Support the validation team on equipment, process and facility validations as required. Responsible for ensuring the environmental monitoring and calibration program requirements are met. Assess and approve change controls as they relate to the facility and Medisca US (MUS) Operations.Leadership
Lead, mentor and develop a team of quality professionals, fostering a culture of quality and continuous improvement. Promote a collaborative approach to problem solving across departments. Encourage open mindset for change management while respecting culture of each location. Foster a culture of excellence by planning and delivering high-quality training, coaching, and performance evaluations for the quality and compliance team. Provide clear and constructive feedback to employees, setting and aligning goals and objectives to drive continuous improvement. Oversee the recruitment, hiring, and onboarding process for new team members, ensuring they receive the necessary training and support to succeed in their roles.Quality Projects and Continuous Improvement
Identify areas of improvement in the quality department and implement risk-based approaches to enhance efficiency and compliance.Qualifications:
Bachelor’s degree in a Science related field. Experience: Seven (7) to ten (10) years’ experience in a managerial role in Quality Assurance/Control. Knowledge of cGMP, FDA, and International Organization for Standardization (ISO) regulations. required. Knowledge of European Union (EU), Therapeutic Goods Administration (TGA) considered an asset. Excellent communication skills required; fluent English (oral & written). Detail oriented, ability to apply analytical thinking and problem solving skills. Proven abilities to apply good judgement, ethical practice and decision making skills. Excellent time management and organizational skills. Required Programs/Software: Knowledge of Microsoft Office (Teams, Word, Outlook, Excel, Access, and PowerPoint) required. Experience dealing with quality management software is considered an asset. Knowledge of Syspro and/or MasterControl programs an asset.What’s in it for you…
We invest time and resources into making sure Medisca is as good as the people we hire.
Work/Life Balance - PTO, vacation policy and paid statutory holidays. Invest in your health - Group Benefit plan and health savings account. Your well-being is important - Wellness program offered. Your Future is Bright - Opportunities to learn and grow within Medisca. Save for your Future - Medisca contributes to a 401k plan when you invest in the plan. Help us grow - Employee Referral Program. We like to have fun - Company events throughout the year. Full time positions - 40 hour work week. Your safety is important - Medisca provides an allocation to purchase safety shoes. Company is growing - New state of the art facility, operational since June 2024.We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.
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