Quality Assurance Manager
- Salt Lake City, UT
The primary responsibilities of the Quality Assurance Manager are to provide leadership of quality relevant to the quality, efficacy, and safety of manufactured products. This includes planning and implementing quality improvement activities, assuring proper quality systems are embedded, establishing objectives for quality within the production environment, and Quality system.
The position will routinely provide feedback to the production operational teams on performance against quality requirements and support in the remediation of operational quality challenges .
- Implement H&PH quality policies and procedures, to ensure RB SLC vitamins and drug products (VMS and OTC) operations meets all regulatory requirements, specifically US FDA and EU GMP (MHRA).
- Establish and approve quality assurance and quality control compliance policy. This position has the responsibility for assuring that all standard operating procedures are reviewed and approved by the appropriate Quality Assurance personnel and those procedures and policies comprising the quality system are properly carried out.
- Provide management for Quality team, relating to the final responsibility for the release VMS/OTC manufactured by RB SLC. The release criteria includes the review and acceptance of all testing data supporting against specification; the review and approval of all documentation generated during the manufacturing and packaging processes; and the overall compliance to cGMP guidelines during the receipt, storage, manufacturing, packaging, and testing of the final product.
- May conduct audits of systems, products, and suppliers.
- Assure that all complaints involving product quality are thoroughly investigated, examined for trends, reported to senior management, and effectively addressed by corrective and preventive actions as deemed appropriate. This position also provides leadership in any recall situation.
- Assure that annual reports for commercial products are completed in a timely basis.
- Support as a primary interface with international, federal, state and local regulatory officials in regards to the manufacture and release of VMS/OTC by RB SLC.
A fantastic opportunity is available for an QA Manager to join our Quality team.
This role is responsible in:
- Quality Assurance Receiving/Goods In team and correlating responsibilities
- Area Quality Senior and Leads for production and operations support
- New Product Development liaison, approvals, tech transfers, and a wide variety of document review and approvals
- Release for Sale team and correlating responsibilities
- Responsible for Trackwise deviations, CAPAs, and Change Controls. Support role for operations Trackwise records and completions.
- Overall record keeping for monthly KPI and associated metrics; reported to Supply Management.
- Integral part in ensuring Customer Service level is routinely delivered.
- Ensure compliance to international standards of GMP (MHRA and FDA)
- Manage systems for QA Receiving Goods In laboratory equipment , procedures, documentation and training.
- Ensure NPD transfer and improvement projects managed to project deadlines
- Continually improves, modifies work practices and procedures to compliment a flexible factory
- Conducts internal and external quality audits as required
- Approves specifications for existing and new product
- Ensuring efficient management of resource to match a very flexible production facility
- Maintain Compliance to GMP in pressure situations
- Maintaining high levels of attention to detail while under customer service pressure, resolving issues within agreed lead-times.
- Communicating failures quickly and accurately particularly where there could be an impact on Quality, Safety, or Efficacy.
- Prompting improvements to gain maximized efficiency and standards.
- Ensuring that RB Quality (Business) Management system meets corporate and regulatory standards, while improving operational effectiveness. Failure could result in regulatory non-compliance with impact on customer service and routine business activity.
- Manages Quality Assurance teams in compliance with Health, Safety & Environmental procedures and regulations.
- To develop and improve the laboratory function to ensure compliance, efficiency, competency and understanding, using accepted business best practice in a fast-moving health products environment.
- Use of electronic systems and records and best practice technology remaining fully compliant but continually improving effectiveness.
- To ensure documentation compliance and user friendliness within the environment
Is this You?
- Expected to have experience in a similar role in the pharmaceutical or an associated industry
- Candidate shall have 8-12 years of Quality Assurance work experience in a Pharmaceutical/Medical device industry.
- Able to manage a large team of people
- Good understanding of pharmaceutical quality systems
- Broad knowledge of pharmaceutical manufacturing processes including multiple dosage forms.
- Qualified Life Science professional - Degree, and/or member of professional body.
- Working knowledge of IT systems and their validation e.g. SAP LIMS, Empower, etc.
- Demonstrated ability to lead the development and implementation of business / quality processes to assure regulatory compliance, leading cross-functional technical personnel, and coordinating the execution of multiple complex projects in a fast-paced environment.
- Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH, and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry.
- Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers.
- Experience using electronic quality management tools such as TrackWise is a PLUS.
- Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem solving teams, etc.
- Must exhibit excellent communication and facilitation skills, both oral and written.
- Analytically capable, able to understand and resolve technical issues
- Project management skills is a PLUS.
In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Back to top