Associate Director, External Site Quality Lead

5 months ago

Kirkland, Canada Organon Full time

**The Position**

The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.

**Responsibilities**
- Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
- Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget.
- Exhibits our company Leadership Behaviors and provides a leadership example for the team.
- Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
- Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
- Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
- May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans.
- Coordinates the development, with the EQA Senior staff, of the EQA budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
- Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
- Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
- Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes building effective quality systems at the EE and continuous improvement activities.
- Manages workload within team scope.
- Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

**Required Education, Experience and Skills**
- Education: Minimum four-year degree in Science, Engineering or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
- Minimum of 8 to 10 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
- Communicates in English, both verbally and in writing.
- Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.

Secondary Language(s) Job Description

**Le Poste**

Le titulaire du poste est responsable de toutes les activités sur le site de l'entité externe (EE) associées à la fabrication des produits de l'entreprise, ce qui comprend la surveillance de la qualité de la fabrication, des tests, de l'emballage, du stockage et de la distribution des produits fabriqués dans une EE et de s'assurer qu'ils ont été produit ou testé selon des processus/méthodes approuvés conformément à toutes les exigences réglementaires applicables, aux dépôts réglementaires et aux politiques de l'entreprise.

Le titulaire du poste s'assure également que des systèmes qualité efficaces et robustes sont suivis pour se conformer aux réglementations, politiques et lignes directrices requises régissant la fabrication externe de matériaux pour l'entreprise (par exemple, petites molécules, protéines thérapeutiques, produits biologiques, vaccins, dispositifs, produits combinés, produits stériles)., excipients, ingrédients pharmaceutiques actifs, intermédiaires, graines et banques de cellules) grâce à une supervision directe, un soutien et des conseils techniques, des conseils aux dirigeants du site et une supervision sur site. Le directeur as

  • External Quality Assurance, Formulation Associate

    5 months ago

    Kirkland, Canada Organon Full time

    **The Position** The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved...

  • Quality Manager

    5 months ago

    Kirkland, Canada Smiths Group Full time

    REF: - INTERCONNECTNA00953- DIVISION: - Smiths Interconnect- JOB FUNCTION: - Operations**Job Description**: Are you an inquisitive individual that has a passion for Quality Assurance? Are you looking for your next challenge with the opportunity to work within a highly regarded team that will support with your learning and development? Then look no...

  • Associate Clinical Research Associate

    5 months ago

    Kirkland, Canada Merck Sharp & Dohme Full time

    **Associate Clinical Research Associate (West)** **Location**:We are currently recruiting two positions in the Western Canada - 1 in Vancouver & 1 in Winnipeg Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy...

  • Quality Manager

    5 months ago

    Kirkland, Canada Smiths Interconnect Full time

    Are you an inquisitive individual that has a passion for Quality Assurance? Are you looking for your next challenge with the opportunity to work within a highly regarded team that will support with your learning and development? Then look no further As a high profile site leadership role, the selected incumbent would be located at the Kirkland/Montreal,...

  • Quality Manager

    5 months ago

    Kirkland, Canada Smiths Group Full time

    Location: North America, Canada, Kirkland- Ref: INTERCONNECTNA00953- Division: Smiths Interconnect- Job Function: Operations**Job Description**: Are you an inquisitive individual that has a passion for Quality Assurance? Are you looking for your next challenge with the opportunity to work within a highly regarded team that will support with your learning and...

  • Clinical Research Associate Manager

    5 days ago

    Kirkland, Canada Merck Sharp & Dohme Full time

    **Clinical Research Associate Manager** **Location: Based in British Columbia or Alberta** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates and to ensure...

  • Quality Assurance Specialist

    5 months ago

    Kirkland, Canada Safran Full time

    **Description du poste**: Job Summary: The objectives of the Quality Assurance specialist are to guarantee the conformity of the products and services delivered to the customers (internals and externals) with regulatory requirements. To ensure that all processes are followed to manufacture and deliver at the standard quality, cost and on time. S(he) conducts...

  • Project Manager, Construction

    5 months ago

    Kirkland, Canada CT Real Estate Full time

    **What you’ll do** The position of Project Manager, reports to the Construction Manager. Working within a high energy team, this is a high profile role responsible to lead, motivate and execute projects with external consultants and general contractors in all aspects of design ,execution and construction while ensuring the team delivers a high level of...

  • Directeur/directrice de La Comptabilité/ Director

    5 months ago

    Kirkland, Canada IQVIA Full time

    **Job Overview** Reporting to the Senior Director Finance, the Director-Accounting is responsible for managing the company’s accounting and reporting functions, ensuring all compliance requirements are met and providing strategic insight to the business within his/her area of expertise. He/she will oversee the accurate recording, measuring and reporting...

  • Quality & Compliance Specialist, Kirkland (Qc)

    5 months ago

    Kirkland, Canada Valeo Pharma Inc. Full time

    *** Contribute to establishing and maintaining high quality and compliance status of all products handled by Valeo Pharma Inc.to meet all Canadian cGMP regulations. Ensure Quality compliance of internal/client audits, supplier qualifications, SOP’s document control, Change Control, CAPA Closure /Effectiveness, APQR, Quality Metrics for cGMP compliance in...

  • Clinical Research Associate II Oncology Monitoring

    2 weeks ago

    Kirkland, Quebec, Canada IQVIA Full time

    Job Title: Clinical Research Associate II Oncology MonitoringAbout the Role:IQVIA is seeking a highly skilled Clinical Research Associate II to join our team in Eastern Canada. As a Clinical Research Associate II, you will be responsible for monitoring and managing clinical trials in the oncology field.Key Responsibilities:Conduct site evaluation visits to...

  • Site Lean Leader

    2 months ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment.This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.The successful...

  • Site Lean Leader

    2 months ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment.This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.The successful...

  • Quality Inspector

    5 months ago

    Kirkland, Canada WECO CONNECTEURS ELECTRIQUES INC. Full time

    WECO Electrical Connectors Inc. Head Office 18050 Trans-Canada Highway Kirkland, QC, H9J 4A1 Canada **Final Inspector,** **Quality Control,** **Kirkland, Quebec** Are you passionate in obtaining products of the highest quality and the rigorous control processes to achieve it? Are you detail-oriented and interested in quality control? Are you energetic...

  • Director of Clinical Project Management

    5 months ago

    Kirkland, Canada Novasyte Full time

    Director, Global Project Leadership IQVIA’s Directors within Global Project Leadership direct and manage the team responsible for clinical delivery of complex; global full service, multi-regional studies and/or programs as well as strategic decision-making responsibility for the project/program. You will hold responsibility for the direction and...

  • Quality Assurance Associate

    5 months ago

    Kirkland, Canada Accord Healthcare Canada Full time

    This is18month full time contract position in Quality Assurance department at Accord Healthcare in Montreal which requires,1-3 years working experience in Quality Assurance area of Canadian Pharmaceutical CompanyAwareness of Canadian GMP requirements as per Health Canada guidanceKnowledge of Health Canada's compliance requirements for an importer/distributor...

  • Site Lean Leader

    3 weeks ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment. This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.Key...

  • Site Lean Leader

    1 month ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment.This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.The successful...

  • Site Lean Leader

    1 month ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment.This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.The successful...

  • Site Lean Leader

    4 weeks ago

    Kirkland, Quebec, Canada Smiths Interconnect Full time

    Job DescriptionWe are seeking an experienced Site Lean Leader to drive cultural change within our operational and business transformation environment. This role demands exceptional organizational, prioritization, and facilitation skills, along with the ability to lead effectively and engage proactively with business leaders and key stakeholders.Key...