דרושים Publishing Associate Regulatory Submissions Management ב-טבע ב-Canada, Toronto

The QA Associate II supports change control management, review, and approval for Commercial quality related activities. This individual is responsible for processing and managing controlled documents that are under the scope of Commercial quality. The QA Associate II performs product launches and releases of imported products (Teva Affiliates and 3rd Party) to market and impact assessment with respect to the critical GMP issues. Reviews supplier documentation related to product launches and releases, validations, deviations, change controls, etc. The QA Associate II also conducts investigations related to deviations, OOS and OOT, and supports drug establishment licensing management, as required. The QA Associate II investigates Product Complaints and ensures the timely closure and approval of the records in QMS as required, and as needed to support with on-time launches of 3rd party product in coordination with internal and external groups. In addition, the QA Associate II supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality.

• Manages change control processes, reviews, and approves, for Commercial Quality related activities.
• Responsible for processing and managing controlled documents that are under the scope of Commercial Quality.
• Provides oversight of activities associated with imported products from Teva affiliates and 3rd Party and interacts with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs.
• Reviews and approves GMP documentation associated with Teva affiliates and 3rd Party supplied finished products including release documentation, deviations, validations, change records, etc.
• Supports completion of stability report updates for products imported from Teva affiliates.
• As required, supports with the drug establishment licensing management.
• Performs release of Teva affiliates and 3rd Party products to Canadian market.
• Liaises with Teva affiliates to ensure compliance with GMPs, adherence to Quality agreements and resolve quality issues.
• Ensures compliant, on-time launches of Teva affiliates and 3rd Party manufactured products in coordination with internal and external groups.
• Investigates, reviews and/or approves product complaints and ensures the timely closure of records in Harmony TrackWise.
• Performs comprehensive and detailed investigations for quality deviations (DRs) in a timely manner. Performs impact assessment for imported products towards Critical Incident Notification / Alerts.
• Performs Executed Batch Record Review for Teva affiliate products.
• Reviews internal procedures and Corporate Standards, performs gap assessments and updates SOPs accordingly.
• Supports with establishing systems and processes for Commercial Quality Canada to align with IM Commercial Quality.
• Supports other Compliance functions and projects as required.
• Supports inspections.
• Leads / manages special projects that require collaboration with cross-function teams and Teva Global Affiliates.
• Other related duties as required.

• Holds a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
• Three (3) + years of relevant experience in Change Control, Documentation, Quality Control and/or Quality Assurance. Knowledge of Health Canada Regulation related to importation requirements. Experience in Word, Excel, QMS
• Preferred: Five (5) years of relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry
• Good working knowledge of SAP, QMS, Excel and Word. Must be proficient in MS word.
• Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Importation.
• Thorough understanding of manufacturing, packaging and laboratory operations.
• Advance writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
• Planning/Organizational skills: Highly organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluated work processes and outcomes
• Problem solving: Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources. Must demonstrate ability to recognize critical situations and respond appropriately. Analyzes relationships among several parts of a problem or situation. Ability to anticipate obstacles and think of next steps. Recognizes multiple casual links: several causes of events, several consequences of actions, or multiple part chain of events. (A leads to B leads to C).
• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs and expectations.
• Strong analytical, time management and organizational skills.
• Excellent verbal and written communication skills.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Quality Assurance Associate will provide support to operations by providing oversight to activities associated with the manufacturing and packaging of bulk and finished products by Teva affiliates and 3rd party suppliers to ensure compliance with GMPs. In addition, will review and approve supplier documentation related to product release, validation, deviation, change controls, etc. In addition, perform release of Teva Affiliates and 3rd party products to market and impact assessment with respect to the critical GMP issues. The Quality Assurance Associate will investigate product complaints and ensure the timely closure and approval of the records in Harmony Trackwise as required, and as needed support with on-time launches of Teva Affiliates and 3rd party product in coordination with internal & external groups.

• Provide oversight of activities associated with the manufacture & packaging of bulk & finished products by Teva Affiliates and 3rd party suppliers to ensure compliance with GMPs.
• Review & approve GMP documentation associated with Teva Affiliates and 3rd party supplied bulk & finished products including release documentation, deviations, validations, change controls, etc.
• Perform release of Teva Affiliates and 3rd party products to market.
• Liaise with Teva Affiliates and 3rd party suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.
• Ensure compliant, on-time launches of Teva Affiliates and 3rd party products in coordination with internal & external groups.
• Investigate product complaints and ensure the timely closure and approval of the records in Harmony Trackwise, as required.
• Perform comprehensive and detailed investigations for quality deviations (DR's) related to Teva Affiliates and 3rd party products in a timely manner.
• Provide metrics to Teva Global/ Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc; Generate/trend monthly and quarterly reports.
• Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner.
• Request stability data from the suppliers and perform stability review for all Teva Affiliates and 3rd party products.
• Draft/revise, negotiate and execute Quality Agreements with manufacturing site, contract packagers, contract laboratories, etc.
• Perform impact assessment for Teva Affiliates and 3rd party products towards Critical Incident Notifications / Alerts.
• Perform Executed Batch Record Review for Teva Affiliates and 3rd party products.
• Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly.
• Perform retain sampling activities: conduct the receipt of retain samples, updating SAP / storage of retain samples and destruction of expired retain samples as per procedures.
• Support other compliance functions and projects as required.
• Lead/ Manage special projects that require collaboration with cross-functional teams and Teva Global Affiliates.

Perform other duties as required.

• Minimum of 1 (one) year relevant experience in Quality Control, Quality Assurance.
• Knowledge of USP, BP EP, compendia methods as well as ability to read and interpret house methods.
• Preferred: 3 (three) + years relevant experience in Quality Control, Quality Assurance or a proven track record within pharmaceuticals.
• Good working knowledge of SAP, LIMS, Trackwise, Excel and Word.
• Good knowledge of SOPs, GMPs and cGMPs applicable to Quality Operations and Manufacturing.
• Thorough understanding of manufacturing, packaging
• Advanced writing skills: Ability to clearly and logically explain ideas in a concise and organized manner with the use of proper grammar.
• Planning/Organizational skills: highly organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluate work processes and outcomes.
• Problem solving skills: Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources. Must demonstrate ability to recognize critical situations and respond appropriately. Analyzes relationships among several parts of a problem or situation. Ability to anticipate obstacles and think of next steps. Recognizes multiple casual links: several causes of events, several consequences of actions or multiple part chain of events (A leads to B leads to C).
• Interpersonal skills: Educates internal and external customers on facts by taking into account differences in level of understanding, needs and expectations.
• Strong analytical, time management and organizational skills.
• Excellent verbal and written communication skills.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Develop and implement communication and corporate affairs strategies to support Teva's goals and objectives in Canada.
• Create and manage content for internal and external communications, including newsletters, website updates, and social media.
• Support executive communications, including speechwriting, presentation development, LinkedIn, and market positioning.
• Collaborate with the marketing team to align communication efforts with marketing campaigns.
• Support the development of plans around Canadian ESG efforts, employee events, and business conferences.
• Lead and collaborate cross-functionally on the strategic use of town halls and leadership meetings, incorporating feedback mechanisms for employee engagement.
• Direct all aspects of internal communications to ensure content complies with Teva's brand strategy and standards.
• Lead the Internal Communications team, fostering a high-performing environment, coaching, and developing team members.
• Develop and maintain relationships with key media contacts across Canada.
• Draft and distribute press releases, media statements, and other communications materials.
• Monitor media coverage and manage media inquiries.
• Develop and execute crisis plans and act as a spokesperson during crisis situations.
• Advise and support senior leadership with strategic guidance on messaging, platforms, and communication plans to enhance employee alignment with organizational goals.
• Drive strategic execution by partnering with the GM to translate the big-picture strategy into actionable priorities.
• Organize and lead leadership meetings and offsites, managing agendas, discussion flow, and action items.
• Interface with regional and global communications colleagues to integrate relevant global strategies and plans.
• Track and analyze the effectiveness of communication strategies and campaigns.
• Prepare reports on media coverage, communication activities, and outcomes.

• Bachelor’s degree in communications, Public Relations, Marketing, or equivalent.
• Minimum of 7 years of related experience in communications, preferably in the pharmaceutical, healthcare, or tech industry.
• Minimum of 3 years of experience in a leadership role, including experience supporting organizations through change.
• Proven track record of driving cross-functional initiatives, ensuring alignment between teams, and guiding projects from planning to execution.
• Exceptional communication skills with written and verbal fluency in English. Upper-intermediate or higher proficiency in French is an asset
• Ability to translate complex ideas into clear, actionable insights.
• High emotional intelligence with the ability to navigate complex dynamics and foster a positive organizational culture.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in using digital communication tools and platforms, including social media, content management systems, and media monitoring software. Openness to integrating AI-powered solutions.
• Results oriented and entrepreneurial.
• Contagious positivity, open to change and able to think out of the box.
• Possess a high level of business ethics, integrity, and professionalism.
• Travel requirement: 10-15%.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

As an HR Process Excellence Manager, you will play a pivotal role in shaping and executing our global strategic roadmap for HR process excellence. Your mission is to design, implement, and continuously improve leaner and more employee experience-driven HR processes that support organizational efficiency and our HR transformation.
You will be driving the HR Process Excellence roadmap and ensuring the implementation and measurable impact of process improvements across all regions and HR functions. You will work closely with global stakeholders to align initiatives with business priorities, leveraging methodologies such as Lean, Six Sigma, and Design Thinking. A key focus will be on automating and leveraging advanced technologies to streamline HR operations, enhance data-driven decision making, and regularly monitor and analyze performance metrics to identify opportunities for continuous improvement.
In addition to driving the transformation of our HR processes, you will ensure excellent change management to foster buy-in and sustainable adoption of new ways of working globally and facilitate global HR forums and training sessions to embed a culture of process excellence and innovation within HR.

You are someone who:

• Has a passion for HR process improvements, operational excellence and automation
• Combines strategic thinking with a hands-on attitude
• Thrives in international, matrixed environments with a global mindset
• Communicates with confidence and clarity across all levels
• Enjoys change management and facilitating collaboration between diverse teams and stakeholders
• Is proactive, structured, and highly result-oriented

Do You Have

• A university degree (Master/Diploma) in Business Administration, Human Resources or a related field
• At least 5 years of hands-on experience in HR, ideally in HR Operations, HR Management, or Employee Experience
• Proven experience in process mapping, optimization, and redesign in a global context
• Expertise in improvement methodologies (Lean, Six Sigma, etc.) and project/change management
• Strong stakeholder engagement skills and the ability to manage resistance
• Proven experience in change management projects
• A global mindset focused on continuous improvement and customer experience
• Excellent written and verbal English skills

Head of HR Process Excellence

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.