Project Leader, Sr. Quality & Analytics

Job Summary

Supports the success of the Global Quality & Analytics team as a senior professional expert, with the following areas of expertise:
•    Global Quality Governance, Metrics and Reporting
•    Global Quality Systems review and approval of proposed changes to Standard Operating Documents and  Quality Management Systems 
•    Technical resource and coach for business units to promote the optimized use of Global Quality Systems 
•    Senior Project Leader for key compliance initiatives and Owner/Assessor of system level configuration change controls
 

Job Responsibilities

Liaise with responsible individuals at sites and functions to ensure consistency, timely availability and accuracy of regular and ad-hoc business-related metrics
•    Identify and highlight quality metric trends and report out on a regular/ad-hoc basis to site/global management
•    Ensure processes are appropriately proceduralized and aligned with existing and new procedures and policies
•    Continuously improve quality metrics through literature searches in the field and, where feasible, employment of latest procedures, tools and techniques
•    Track and monitor the status of key milestones of the global quality system programs through the participation and coordination of internal meetings and quality forums, and review available information systems to ensure alignment with identified deadlines
•    Act as key Quality representative working on special projects, interacting at all levels of the organization, providing leadership, co-ordination, and project management as required in support of Quality & Compliance department goals and objectives
•    Support working on systems projects (i.e. Trackwise), interacting at all levels of organization, providing co­ordination, and project management as required. Superuser/Backup for TrackWise system, contribute to and co-ordinate systems awareness programs including planning, development, implementation and training
•    Participate in corporate, customer and regulatory authority inspections. Contributes in pulling ad-hoc metrics, drafting responses, maintaining files, tracking commitments and reporting on status to closure
•    Support Global Quality System Process Owners/Super users Network team, facilitate meetings and provide updates as needed; conduct global system training as qualified trainer (as required) 
•    Key contact for global systems access and data entry requirements (e.g.  Trackwise access for Apotex Pharmachem sites) assuring consistency at a global level
•    Keep abreast of new regulations / guidelines, changes in GMP interpretation, emerging regulatory and industry trends, informs management of developments, makes recommendations on procedure / policy changes and ensures timely development, implementation and execution in alignment with global leadership teams
•    Effectively manage workload and prioritize work in line with the overall department and company objectives and requirements; provides routine progress reports and keeps management informed of on-going activities
•    Provide management with the proper notification of potential issues relating to quality and compliance projects and provides routine updates on status of activities
•    Use sound, technical judgment in making decisions and recommendations, and adhere to cGMPs and applicable Standard Operating Procedures when performing job responsibilities and assigned tasks
•    Foster a good working relationship within the company, affiliated companies and with customers
•    Perform all work in accordance with all established regulatory and compliance and safety requirements, adheres to company policies and procedures and conducts oneself in a professional manner
•    Work in a safe manner collaborating as a team member to achieve all outcomes

• 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   

Job Requirements

Education
o    Minimum Bachelor of Science degree or equivalent in a related discipline

Knowledge, Skills and Abilities
o    Strong working knowledge of cGMPs, ICH guidelines and Pharmacopoeia requirements
o    Certification and /or experience in Project Management and Six Sigma is an asset
o    Detail-oriented with strong analytical, investigative, technical and quality report writing/reviewing/approving skills
o    Demonstrated ability to work independently and effectively manage multiple priorities in a fast-paced and changing environment
o    Ability to manage internal and external relationships and lead or work in focused cross-functional groups with effective outcomes
o    Excellent English oral and written communications and interpersonal skills
o    Intermediate to advanced computer skills in MS Excel, Word, Access, Microsoft Project, required

Experience
o    Minimum of 5-7 years’ experience in the Pharmaceutical industry in the area  of Quality Assurance
o    Strong practical experience in interpretation and application of cGMP pharmaceutical regulations and guidelines (Health Canada, US FDA, Eudralex, regulatory guidance and ICH), with focus on quality systems
o    Sound working knowledge of cGMPs, ICH guidelines and Pharmacopoeial requirements
o    Demonstrated ability to coach others with a focus on changing behaviour
o    Experience with SAP and TrackWise is an asset
o    Experience with statistical methodology is an asset