Jubilant HollisterStier , a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Senior Manager, Quality Assurance to join our team!

What We Offer:

A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive health, dental, and disability insurance programs, a group retirement plan, and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier is equipped to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier is proudly part of the Jubilant Pharma family. For more information, visit www.jublhs.com.

We continue—with the utmost care for the environment and society—to create value for our clients and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you’re ready for a rewarding challenge, we invite you to take the first step and apply today!

Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We foster an inclusive environment where our employees can thrive and where differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health overall.

Purpose of the Job:

Establishes and maintains Quality Assurance Systems and Quality Operation teams, which ensures that all products which are manufactured, as agreed upon contractually with customers, meet the internal standards of Jubilant Hollisterstier and those of the regulatory agencies (HPFBI, FDA, EU, etc.). This is accomplished through the following activities:

• Change Control Management
• Specifications and Method of Analysis
• Annual Product Review
• Standard Operation Procedures (SOPs)
• Batch review and release(including analytical and production)
• Management of the incident reports, investigations, CAPA (Corrective Action & Preventive Action)
• Provide quality oversight of manufacturing and packaging activities
• Responsible for the site GMP training program

Responsibilities:

• Oversees preparation, review and maintenance of specifications for finished products, raw materials, and packaging components in SAP ensuring technical accuracy and compliance to customers’ requirements, GMP, and compendia standards.
• Oversees all activities associated with semi, finished product, raw materials and packaging components releases, the review of all related documentation to ensure conformance to GMP, customer requirements, and government regulations.
• Directs activities such as: Change Control coordination, annual quality product review (APQR), Standard Operating Procedures (SOPs) and Review and Release of records (incoming and finished product) prior to release.
• Ensures that drug product deviation investigations are handled and resolved on a timely basis. Performs the quality review and approval of investigation reports for non-compliances and quality incidences. Ensures that the contents of the investigation reports are in compliance with current GMP regulations, customer requirements, Jubilant policies, directives and procedures.
• Ensures that product complaints are handled and resolved on a timely basis. Ensures that the contents of the complaint investigation reports are in compliance with current GMP regulations, customer requirements, Jubilant policies, directives and procedures.
• Manage the investigation process from incident reporting, interviews, gathering of information, root-cause analysis, investigation reports and CAPA generation to meet company and global objectives, as well as follow-up of CAPA effectiveness.
• Provides Quality Assurance presence on the production floor to ensure quality oversight of manufacturing and packaging activities. Answers customers’ inquiries / issues on their products as required.
• Reviews and approves GMP documents related to Quality Systems such as Master batch Records and associated change requests, Manufacturing Investigation reports, complaints, procedures, trend reports, analytical protocols, analytical reports, etc.
• Ensures the maintenance and compliance of the Site Training procedures and the overall GMP training program for the site.
• Assure support to the SAP Quality Module.
• Resolves and documents critical problems pertaining to the quality systems and processes. Tracks and trends key quality performance indicators. Conducts appropriate follow-ups as required. Provides periodic status to Senior Management as requested.
• Translates applicable regulatory requirements, as well as customers’ requirements into Quality Systems and ensures communication of these to appropriate personnel.
• Ensures logistics for and control timely billing for the customers services such as stability program and APR.
• Act as quality representative to answer client’s questions and concerns on behalf of JHS Montreal.
• Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives, and key performance indicators.
• Performs additional duties as assigned by Management

Education & Experience:

Education Qualification (Highest):

• Minimum BSc in Chemistry, Microbiology, or closely related discipline.

Experience Required:

• Minimum of ten (10) years of experience in Quality Assurance / Control and Compliance within the pharmaceutical or healthcare industry with at least five (5) years in management role.
• Experience interacting or dealing with regulatory agency.
• Broad experience with regulatory and GMP standards associated with process control and validation, manufacturing, packaging and testing

Skills Required:

• Strong knowledge of pharmaceutical processing techniques.
• In-depth knowledge of cGMP regulations for Canada, US, Europe and compendia standard (USP, BP, EP), and chemical and microbiological testing methods.
• Computer literacy (Microsoft Office, TrackWise, MasterControl, ComplianceWire and SAP environment).
• Bilingual (French & English).Proficiency in English is essential

Salary ranges from $86,929 to $144,882 depending on education level and years of experience.

If qualified individuals with a disability need assistance in applying for this position, contact Human Resources at MTL-TalentAquisition@jubl.com informing us regarding the nature of your request and providing your contact information.

Join us, and be a part of our global success story!