Title: Technical Manager, Global Annual Product Quality Review (APQR)- 1 Year Contract
Department: Pharma Technical Quality & Compliance (PTQ)- Global
Location: Mississauga Campus
Multiple Positions Available!
The Technical Manager, Global APQR, executes the Global APQR process per GSP037 “Annual Product Quality Review (APQR)” for Roche commercial products including the annual cross-site review and analysis for trends and issues required to assess the overall state of control throughout the product and process life cycle.
- Prepare E2E APQRs for Roche commercial products. This process requires the ability to evaluate cross-functional data and to apply analytical tools to multiple inputs (including site APQR modules, global data contributors and electronic systems).
- Perform comprehensive assessment of product quality by analyzing/evaluating APQR data to ensure state of control for manufacturing processes, analytical method performance and all key quality attributes throughout commercial product life cycle.
- Collaborate and communicate with all APQR participants to ensure that they provide accurate APQR data and analyses which lead to valid conclusions.
- Identify and communicate process and/or product quality issues in a timely manner. This includes recommendations for resolution and/or working to determine and implement new procedures (for evaluation of product or business process).
- Propose APQR action items ensuring the appropriate quality system elements are deployed.
- Develop and maintain a platform to monitor global APQR metrics (safety, quality, delivery, engagement and cost) and apply Lean Production System (LPS) principles to continuously improve the process.
- Provide global support as Subject Matter Expert for APQR and any Areas of Expertise, including metrics. This includes process training to participating functions and their management.
- Maintain readiness of the APQR process and E2E reports during regulatory agency inspections and internal/external audits; present during inspections as needed.
- Perform assigned tasks in compliance with global health regulations and Roche policies and procedures. Interpret applicable agency regulations to ensure ongoing compliance.
- Perform any other tasks as assigned to support APQR and Quality oversight activities (e.g., annual schedule, SQDEC metrics, systems/tools maintenance, etc.).
- Set personal performance goals and establish work priorities to meet goals and timelines for assignments.
- Work independently to actively contribute to the success of the Global APQR team objectives. Ensure cross-functional team deliverables are completed in a compliant, accurate, high quality and timely manner.
- Leverage matrix leadership to coordinate activities of varying complexity which are needed to meet team objectives and support the APQR business process across the Roche network.
Additionally, the Senior Technical Manager:
- Delivers E2E reports per requirements in GSP037.
- Contributes to the performance metrics and overall Quality assessment and reporting as part of the APQR business process.
- Identifies and escalates issues proactive and/or product quality concerns.
- Proposes APQR actions items, as needed.
- Responsible for the development and maintenance of the tracking and reporting platform for APQR related compliance and business metrics.
Education and Experience
- B.A., B.S. or Higher degree (preferably in Life Science), and five years of applicable cGMP pharmaceutical or biopharmaceutical or related industry, or an equivalent combination of education and experience.
- Experience in routine (business and/or compliance) metrics reporting processes.
- Experience collaborating in a global setting to support product teams and global quality initiatives is a plus.
- Technical expertise in small and large molecule drug substance and drug product manufacturing processes and associated control systems. Knowledge of medical devices and device combination products is desirable.
- Experience with data analytics (IT platforms, Tableau) and technical writing is a plus.
- Experience with data acquisition is desired
- Knowledge of German language is an asset
- Demonstrates strong knowledge of Global pharmaceutical/biotechnology industry regulations, and GMPs as well as Roche standards and guidance documents. This includes the ability to interpret standards for implementation and review.
- Demonstrates experience in Quality and pharmaceutical or biopharmaceutical manufacturing.
- Demonstrates strong knowledge of analytical data, critical thinking skills, proficiency in the application of statistics and proficiency across technology platforms.
- Demonstrates excellence in communication. Must communicate clearly and professionally both in writing and verbally, including effective facilitation skills. Fluent in English.
- Ability to to resolve complex technical and quality issues; extract optimized business results through skillful collaboration with team members without formal authority.
- Ability to build relationships and work with interdisciplinary, global, teams in collaborative cross- functional settings.
- Drives for continuous improvement and operates with lean mindset.
- Demonstrates resourcefulness and proactive dynamic learning potential.
- An additional language proficiency to support Roche network regional collaboration preferred.
- Ability to travel according to the needs of the business (estimated 10% or less).
Qualified candidates are encouraged to submit cover letter and resume no later than January 25, 2021.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
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