Quality Operations Manager

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click on the link to learn more about Evonik from our employees:
RESPONSIBILITIES

Leadership/ Functional:

- Lead a team of Quality personnel (~ 4 direct reports), and be a strong Quality partner/ collaborator to drive operational efficiencies to achieve sustainable quality compliance and meet the business objectives of the site
- Build strong relationships with the Quality team, internal stakeholders (such as Development & Formulation, Supply Chain, Project Management, Production, _etc_.), Evonik colleagues of other sites, external suppliers, and clients to prioritize on-time delivery of products/ materials/ services that are quality compliant and fit for its intended purpose.

Operational Excellence:

- Put in place and manage all activities related to shop-floor quality operations in accordance with current regulatory requirements/ expectation, corporate policies/ procedures, and industry standards (primarily include shop-floor surveillance of aseptic processing; Quality oversight of qualification/ validation, pest control, environmental monitoring, GMP manufacturing, Deviation investigations, release of materials/ products, Quality review and approval of analytical data and GMP documents, management of Product Recall)
- Proactively improve the efficiency and effectiveness of the responsible processes
- Ensure the day-to-day QO activities are prioritized and performed efficiently and effectively in accordance with approved SOPs, GxP and EHSS requirements.
- Provide direct management of the QO team (includes but not limited to recruitment, development of annual objectives and performance reviews)
- Coach and be a mentor to the responsible Quality team; create development/ learning opportunities for the team to enhance their competencies.
- Participate in the budgeting process and actively manage the allocated resources to assure sustainable quality compliance and business continuity.
- Support site internal project(s) and temporary assignment(s) as assigned by Quality Management

Quality Compliance:

- Develop, maintain, and update applicable Quality related SOPs and documents to assure the procedures are compliant with GMP, EHSS and company requirements.
- Stay abreast of current regulatory (e.g., ISO, ICH, FDA, EMA, and Health Canada) & industry guidelines on topics as related to the scope of this job description.
- Actively participate in Deviation investigations and audit activities
- Provide quality guidance to stakeholders and SMEs to assure deviations are adequately investigated to determine root cause in a timely manner.
- Where applicable, timely establish appropriate responses and “SMART” CAPAs to address investigations and audit findings.
- Actively support relevant activities as related to customer complaints (includes timely investigation, reporting, and final closure)
- Actively participate in periodic Quality Management and Annual Management reviews
- Responsible for managing the site Notification to Management process.

Environmental, Health, Safety, and Security (EHSS):

- Adhere to all EHSS programs, rules, and procedures of Evonik.
- Assume personal accountability for individual behaviors related to EHSS activities.
- Have appropriate knowledge, training, and tools (e.g., don applicable PPE) prior to performing a task.
- Complete all required EHSS training and remain current with applicable learning plans.
- Report all injuries within the same shift of the incident occurring.
- Inform direct supervision of any EHSS hazards or concerns in the workplace.

**REQUIREMENTS**:

- BSc. in chemistry, biological/ applied sciences, pharmaceutical engineering, or equivalent, with 8 years of work experience in GMP regulated environment
- Minimum 5 years of such experience in the Quality unit, and 2 years in supervisory role.
- Work experience in microbiology and/ or sterile manufacturing would be an asset
- Detail oriented to assure accuracy of data and information.
- Excellent technical writing, problem-solving, and communication skills.
- Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.
- Possess effective and professional interpersonal skills with abilities to influence others across multiple functions.
- Self-motivated with abilities to work in an undefined environment.
- Must be flexible and willing to provide off hours support, as needed to support GMP operations.
- Ability to perform wor