Job Description

The Position

Title: Technical Manager, Global Annual Product Quality Review (APQR) & Complaint Operations

Department: Pharma Technical Quality & Compliance (PTQ)- Global

Location: Mississauga campus-based position

Duration: 24 Month Contract/CDIP

# Roles: Multiple Roles Available

About the Role:

The Technical Manager, Global APQR & CO, executes the commercial product evaluation process per GSP037 \xe2\x80\x9cAnnual Product Quality Review (APQR)\xe2\x80\x9d for Roche products including individual sites, the annual cross-site and E2E review analysis for trends and issues required to assess the overall state of control throughout the product and process life cycle, and, if necessary, recommends appropriate actions for product quality issues.

Additionally, the Technical Manager:

Delivers APQR reports per requirements in GSP037.

Contributes to the acquisition and visualization of data to support the development of APQR reports and maintenance of the global process.

Contributes to the performance metrics and overall Quality assessment and reporting as part of the APQR business process.

Identifies and escalates complex issues related to global processes. Work with APQR stakeholders to resolve identified issues.

Proposes APQR actions items, as needed.

Provides training and guidance as needed regarding the Global APQR process, including planning and the implementation of procedures.

This role is a deputy for and may be deputized by Technical Manager roles in the Global APQR organization (Technical, Senior and Principal).

Your Key Accountabilities

Prepare 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). Prepare an evaluation of global complaint information in order to assess product quality.

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 the commercial product lifecycle.

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 the determination of new methods (for evaluation of product or business process). Implementation thereof may be independent or performed as part of a team.

Propose APQR action items ensuring the appropriate quality system elements are deployed.

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 a Subject Matter Expert for APQR and specific Area of Expertise. This includes process training and guidance on APQR requirements to participating functions and their management.

Maintain readiness of the APQR process and product 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.

Our goal is to build a flexible pool of Quality resources. Part of this role might therefore be other quality work to match business need with employee interest.

Who You Are:

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 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 analytics (IT platforms) and technical writing is a plus.

Knowledge/Skills/Competencies

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.

An additional language proficiency to support Roche network regional collaboration strongly preferred (especially German).

Ability to lead cross-functional teams to resolve complex technical and quality issues; extract optimized business results through skillful collaboration and influencing with matrix team members without formal authority.

Proactive in taking initiative and responsibility. Ability to build relationships and work with interdisciplinary, global, teams in collaborative cross- functional settings.

Drives continuous improvement and operates with a lean/agile mindset.

Demonstrates resourcefulness and proactive dynamic learning potential.

Ability to travel according to the needs of the business (estimated 5% or less).

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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche