Sr. Project Manager, Quality Assurance (QA)

Evonik • Burnaby, BC

5d • $101,500 - $135,300 • Hybrid

About The Position

EVONIK Vancouver Laboratories (VAN), the operating drug delivery service site of Evonik Canada Inc., is a Contract Development and Manufacturing Organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex delivery-based drug formulations. EVONIK has a successful track record of helping Customers move their programs forward. Evonik’s Vancouver business operations is a development partner to the world’s pharmaceutical companies for parenteral lipid nanoparticle drug products. As an enabling contract development manufacturing organization (CDMO) partner, we offer drug formulation design, process development, scale-up, and clinical production. EVONIK’s range of services extends from initial formulation prototype identification, manufacturing process development & scale-up, analytical method development & validation to support raw material, in-process, release and stability testing, all the way through to sterile product manufacturing under GMP for Phase I-II clinical trials. Products include the LIPEX® line of Extruders, which are designed to enable small-scale to commercial scale manufacturing of liposomal drug products. With over 25 years of experience and having transacted business in about 50 different countries, Evonik offers an excellent Total Rewards Program including: Competitive base compensation & bonus; employer paid health & dental benefits complimented with wellness education sessions; Financial planning resources & savings plans including RRSP & Defined Contribution pension plans; Generous vacation and paid time off to support Community Volunteer activities; Financial assistant for fitness memberships. And there is more...access to a Comprehensive Health Promotion program and Regional and Global resources for ongoing training and development. Best of all, you will work within a great team of professionals in an engaging workforce who value trust and openness. Are you looking to join a dynamic company with an exciting and expanding future in the pharmaceutical industry? Then Evonik is the next step in your career. Grow with us!

Requirements

• Minimum B.S. degree in chemistry, biology, microbiology, biomedical or chemical engineering or equivalent education.
• Preferably ten (10) to twelve (12) years’ experience in Quality Assurance/Quality Control, preferably in the biopharmaceutical or pharmaceutical manufacturing industry (early-phase and/or commercial), thereof at least 2 years in a leadership position.
• Experience with hosting foreign and domestic regulatory inspections (US-FDA, EU authorities, Health Canada)
• Knowledge of cGMP requirements and experience in the application and interpretation of cGMP requirements for finished dosage forms.
• Strong organizational skills.
• Advanced problem-solving skills.
• Advanced written and verbal communication skills.
• Excellent interpersonal skills.
• Strong leadership skills
• Knowledge of available Office software systems including Word, Excel and Access.
• Proven experience in pharmaceutical regulatory requirements.
• Experience enables job holder to deal with the majority of situations and to advise others.
• Results Orientation
• Redesigns practices and processes for breakthrough results
• Significantly improves organization’s practices, processes and quality
• Senior fluency in quality risk management principles and risk tool usage, including strong ability to mentor others in Quality Risk Principles and workflows
• Role Orientation / Strategic Orientation
• Leads improvement areas, redesigns processes and manages QA activities with best practices
• Supports definition of standards for quality systems and compliance
• Supports Director, Quality with setting the annual QA priorities and defining specific plans, with team involvement
• Facilitates cross-functional team activities
• Leads collaboration within organization
• Sets model for collaborative culture and leadership
• Understands and commits to demonstrating high emotional intelligence (self-awareness, self-regulation, empathy, social skills, motivation) and demonstrates medium to high emotional intelligence
• Commitment to support and develop peers, as applicable, with the goal to reach full potentials
• Collaboration and Influence
• Facilitates cross-functional team activities
• Leads collaboration within organization
• Sets model for collaborative culture and leadership
• Understands and commits to demonstrating high emotional intelligence (self-awareness, self-regulation, empathy, social skills, motivation) and demonstrates medium to high emotional intelligence
• Commitment to support and develop peers, as applicable, with the goal to reach full potentials
• Technical Proficiency / Business-Focused Proficiency
• Advanced supervisor level expertise with broad, advanced knowledge of GMP requirements for Manufacturing control, batch records review, upstream, downstream and/or filling operations and product release requirements and quality systems.
• Advanced level expertise with broad, advanced knowledge of Quality Systems (Change Control, Deviations, Investigations, Root Cause Analysis, CAPA and Risk Assessments).
• Demonstrates excellent judgement, technical competence and knowledge critically essential for the role.
• Ability to coach and mentor QA team members and other department colleagues in their area(s) of expertise.
• Demonstrates broad awareness and efficiency in addressing diverse business, quality and organizational challenges
• Acts with integrity, values others’ perspectives, ensures transparent, collaborative action and communication, actively listens, commits to active listening, holds themselves accountable

Responsibilities

• Maintain and revise QA related procedures, as needed.
• Maintain cGMP training systems and perform on-site team member training in Quality related matters
• Ensure GxP support and oversight, as applicable, for relevant site functions and activities
• Support QA team members with Senior QA level knowledge, experience, guidance, coaching and mentoring, as required
• Perform QA batch record review and disposition of manufactured early phase clinical product batches.
• Provide final QA approval of investigations and disposition of any impacted product batches.
• Evaluate deviations and propose batch rejections, if applicable.
• Perform QA review and approval of Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data
• Perform QA review and approval of Investigation of non-conforming product
• Perform QA review and approval of Investigation of out of specification (OOS) results
• Manage and approve Change Controls, as required for facilities, equipment, systems and processes, Corrective Action/Preventive Action (CAPAs), and Deviations
• Provide direct or provide QA resources to support process development teams
• Perform or support internal audits/self-inspections
• Perform or support qualification of suppliers
• Perform QA review and approval of Facility and equipment qualification protocols and final reports
• Perform QA review and approval of Cleaning verification protocols
• Perform QA review and approval of Analytical test method validation documentation
• Provide or support QA review and approval of analytical methods, standards and specifications
• Support, coordinate and/or host customer audits as required.
• Support audit responses creation and execution, as needed.
• Effectively communicate with client QA personnel as project support
• Provide QA support for development of validation strategies and validation plans, including Computer System Compliance (CSC) efforts.
• Establish and manage QA tracking and trending of program measures and the preparation of periodic reports for management review.
• Maintain appropriate KPI´s to monitor performance and improvement.
• Propose and develop continuous quality initiatives to improve efficiency and/or improve the level of control and compliance.
• Support and promote the company safety program by obtaining and using all personal protective equipment as appropriate, observing all safety procedures and practices, and assuring that other employees similarly use personal protective equipment.
• Perform other duties as may be required by management.

Benefits

• Competitive base compensation & bonus
• employer paid health & dental benefits
• wellness education sessions
• Financial planning resources & savings plans including RRSP & Defined Contribution pension plans
• Generous vacation and paid time off
• Community Volunteer activities
• Financial assistant for fitness memberships
• Comprehensive Health Promotion program
• Regional and Global resources for ongoing training and development

What This Job Offers

• Job Type: Full-time
• Career Level: Senior