Note: This is an on-site role with the flexibility to work from home in accordance with Evonik's Smart Work Program. Target Salary Range:
$101,500 - $135,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data)
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 the following, as needed:
- Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data
- Investigation of non-conforming product
- 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 the following:
- Facility and equipment qualification protocols and final reports
- Cleaning verification protocols
- 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.
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, 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.
Additional CompetenciesResults 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
Your ApplicationTo ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:Robin Rose
Company is
Evonik Canada Inc.
