Program Manager, Global Quality

Job Summary

Act as a leading member of the QA-Global Policy & Standards department, in collaboration with SMEs/stakeholders, for the generation of technical platforms & functional databases and data collection systems.

Manage Document Management Systems across the Apotex global network to support the development and implementation of global programs, structures, standards, systems, operations, procedures and processes.

lndependantly lead projects for the upgrade of, changes to, and new implementation of Global systems and technical/software applications.

Responsible for project planning, task assigning, prioritizing, authoring and review of qualification activities for GxP Document Management Systems in accordance with regulations and defined Apotex quality standards and policies.

Support the maintenance of global documents, such as Global Policies (GPOLs), Global Standard Operating Procedures (GSOPs), Global Quality Guidelines (GQGs) and Global System User Manuals (GSUMs).

Job Responsibilities

• Ensure alignment of Apotex global sites and affiliates, including external manufacturing and R&D, towards Quality Management Systems (QMS) regulatory requirements.
• Act as a main compliance lead for Apotex Inc. and affiliate sites documentation, document management systems and system remediation activities.
• Support the initiation, review and revision of global docments within required timelines in line with required regulatory standards.
• Act as a technical resource for global documentation management to ensure appropriate information flow, communication and transparency.
• Maintain document management procedures to regulate change implementation, ensuring document management system compliance through its life cycle.
• Ensure quality is built into systems and processes for compliant decision-making and accountability from all areas of the business.
• Develop and maintain procedures/tools for validation and compliance with cGMP impacting document management systems to all regulations including 21CFR Part11.
• Perform quality assessments for document management systems validation status and change controls status.
• Author and review validation documents such as User Requirement Specifications, Validation Plans and Validation Summary Reports as per defined validation approach, along with the respective change controls.
• Coordinate with GIS, CSV and QA stakeholders to ensure timely completion of document management systems validation testing related tasks.
• Lead departmental initiatives in support of continuous improvement of Quality Management Systems and Document Management Systems.
• Provide internal consulting expertise, coaching and mentoring business users, project teams and sites/centralized functions on document management systems and change management processes.
• Build and maintain external relationships to enhance and improve global quality (e.g. Vendors, Consulting groups, etc.).
• Support internal and external audits as required.
• Support execution of activities related to global document assessment and implementation completion and creation/revision of site/centralized function SOPs.
• Manage and maintain the Global Documentation Website and electronic library.
• Manage departmental metrics and Key Performance Indicators applicable to GPOL and GSOP distribution and sustainability activities. Perform critical analysis of data (e.g., trends, risk, etc.) and prepare additional reports as requested.
• Support Learning Operations, Systems Training and Certification Programs as required.
• Support global projects/initiatives towards continuous improvement.
• Demonstrate personal leadership attributes incorporating a commitment to on-going professional development and continuous learning.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Post-secondary education required in Chemistry, Biochemistry, or a related discipline.
• Knowledge, Skills and Abilities
  • Sound knowledge of the Health Canada, FDA, and other global pharmaceutical regulations.
  • Thorough understanding of GMPs and GAMP standards including validation process.
  • Superior interpersonal, communication, facilliation and organizational skills.
  • Demonstrated leadership skills with decision making ability and excellent problem solving skills including analytical and critical thinking.
  • Ability to effectively communicate with senior level leadership.
  • Proven effective project management skills, with ability to manage time effectively, work independently and manage multiple priorities.
  • High proficiency with databases such as MS Office, Word, Excel and Power Point.
  • Solid understanding of IT systems (e.g. document management systems, databases and various software packages).
  • Demonstrated ability of having cross functional/team experience.
  • Excellent written and oral English communication skills with demonstrated technical writing skills.
• Experience
  • Minimum 5 years of progressive experience within the pharmaceutical industry.
  • Minimum 3 years of validation experience in GMP regulated industry.
  • Experience working with cGMP procedures in the pharmaceutical industry.
  • Experience in authoring/executing validation plans, OQ qualification protocols and reports for document management systems.
  • Relevant experience on document management systems applications; SAP system, network and enterprise content management systems.
  • Extensive project management experience.
  • Strong customer service orientation.
  • Knowledge of software testing tools is preferred.