If you would like to work for a Quality Consulting Firm with multiple fortune 500 companies as clients in the Life Sciences field and would like to design and manage internal and suppliers’ quality programs for them, then this is your job.
What to expect: Insight on the current opportunity, overall SQA focus will be and what type of environment will the candidate be working in?
You will be part of the Field Engineering team who manages the technical design, development and deployment of Life Sciences clients consulting, audit, inspection, remediation, and improvement programs. Will be involved in assuring that all stages of the lifecycle of product such as clinical, pre-production and commercial production and post market surveillance are compliant to regulatory guidelines and standards.
What you’ll do: Specifics on the duties of the role, commodity, location and frequency.
•Work with Clients to comprehensively understand and record requirements in a way that allows the development of adequate Program Scope with execution that maximizes sales and margin for the SQA business model. In addition, objectives and measures for projects must be clearly defined, to highlight successes and build a baseline for follow-up business opportunities.
•Kick off and monitor managed programs for Life Science clients for multiple grades of final products and raw materials.
•Identifying opportunities for the provision of additional services with existing clients.
•Conducting regular reviews with cross functional team to identify program trends and/or irregularities and bringing them (and subsequent recommendations) to the attention of the Client.
•Analyzing the activity of client programs and providing meaningful feedback and direction. This may include a recommendation for the reduction of one kind of activity in one area (e.g. on-site audits of low-risk suppliers), or recommendation for the increase of one kind of activity in another area (e.g. in-depth Assessments for a critical suppliers).
•Develop plans for associate monitoring, training, and development.
•Analyzing SQA’s internal Life Science accounts for opportunities for improvement and optimization.
•Maintain SQA to up to date regulatory requirements and update programs based on changes established.
•Performance of qualification/technical visits at vendor sites to support the appropriate vendor selection and supplier qualification.
What you’ll need: Specific qualifications required to be considered for the role
•Thorough understanding of national and international laws, regulations and guidelines regarding GMP
•Experience in interacting with authorities (EU, FDA, etc.)
•Broad experience in Quality Management, including the development, establishment, and maintenance of quality systems (GXPs)
•Experience in GMP Lab operations (knowledge of analytical test method, analytical equipment uses, software systems, OOS process, etc.)
•Strong resolve and steadfastness in upholding quality standards at external partners as well as internally
•Strong leadership skills
•Ability and experience to work in a cross-functional team and an international environment.
•Experience in establishing Quality- and Technical Agreements
•Superior written and verbal communication, including technical writing.
•Bachelor’s or advanced degree in relevant scientific/engineering discipline.
•Demonstrated success with engineering project management and leadership.
•Supplier Quality Engineering experience, regarding:
•Deviation Management
•Change Control Management
•Equipment Qualifications
•Laboratory Controls
•Process Validations
•CAPA
•Risk Management Tools
•Batch Record Review Process
•Supplier Management
COMPENSATION:
115-125K a year with good monthly and yearly bonus structure + benefits (medical insurance + 401K). Travel required 30% of time.