Quality Manager, External Compliance
- Salt Lake City, UT
Using risk based methods develop and improve co-packer quality assurance program at SLC site in order to maintain ongoing approval status of co-packer base to Reckitt Benckiser Salt Lake City. Conduct co-packer assessment and approval for new co-packers which will include co-packer site audits. Manage quality issues arising from non-conformance of finished products so that service and quality standards are maintained and manage any resulting quality improvement program required at co-packers
Maintains co-packer quality assurance program.
Responsible for establishing procedures, performance metrics and administering quality relationships with co-packers to ensure their activities are fully compliant with cGMP and RB guidelines to minimize risk to consumers, company and brand name.
US and some international travel to audit co-packers.
The approval (or rejection) of new co-packers. Recommends suspension of supply on the basis of failures in co-packer quality management systems.
Work closely with different organizations within the business to resolve any issues with co-packers.
Propose quality improvements to co-packers and monitor implementation.
Coordinate with distribution personnel quarantine of stock where there is doubt on assurance of quality, safety and efficacy of finished products to be sold.
Failure could lead to consumer injury or dissatisfaction, adverse regulatory input, damage to Company and/or Brand image adverse operational performance.
Approval of co-packers within required timescales.
Assure co-packers are compliant with GMP regulations and routinely deliver materials that meet RB and regulatory specifications.
Manage co-packer improvements to finished pack quality, operational performance and increased assurance of quality, safety and efficacy of finished products sold.
Effectively prioritise workload on the basis of risk assessment and generation of business benefit.
Deliver quality, customer service and operational effectiveness when issues arise with co-packers.
Support RB reduced testing programme by delivering robust justifications, which assure compliance and performance in line with RB policy and would withstand regulatory agency scrutiny.
A fantastic opportunity is available for a Quality Manager, External Compliance to join our Quality team.
Develop, implement and continuously improve processes of the ongoing co-packer assessment and re-approval program based on risk. The GMP regulatory compliance of RB must be maintained with regard to co-packer assurance.
Develop, implement and oversee co-packer quality agreements.
Collation of information supporting continued approval of co-packer and ensuring RB continued confidence in the co-packer to perform at the required standard to supply RB (using a database or similar format).
Monitoring the quality performance of existing co-packers using performance metrics and ensuring their activities are fully compliant with applicable regulations.
Independently schedule, conduct and report initial, routine and follow up audits of co-packer quality systems. Establish appropriate corrective actions plans with acceptable timescales with the co-packer to address observations from the audits.
The approval (or rejection) of new co-packers.
Work closely with Procurement, Factory Operations and other Quality groups to resolve quality issues with co-packers that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance.
The approval (or rejection) of major deviations and changes controls purposed by co-packers.
Assure proper notifications are communicated to both the co-packers and inside of RB.
Partner with co-packers and internal departments to develop improvements at co-packers when necessary. Ensure implementation at co-packers is conducted in a compliant manner and monitor output from changes.
Maintain knowledge of current regulatory and industry compliance trends and adopt co-packer qualification program strategies as appropriate.
Prefer BS/MS degree in a scientific or engineering discipline or equivalent experience.
Minimum of 5 to 8 years' experience in pharmaceutical and/or dietary supplement industry in Quality Assurance with at least 1 year participating as a lead GMP auditor role. Prefer CQA certification or equivalent.
Knowledge of pharmaceutical/dietary supplement quality industry regulations FDA, GMP, GLP, ICH Q7, 8, &9; 21 CFR 11, 210/211, 111, and 820 USP/EP Compendia and ISO 9001 and ISO13485.
Broad understanding of manufacturing operations and solid knowledge of regulatory requirements for pharmaceutical/dietary supplement processing.
Ability to travel at least 50% of the time.
Strong interpersonal, oral and written communication skills.
Well-developed influencing skills. Diplomatic and tactful in difficult co-packer situations.
Excellent problem solving skills, and experience resolving/explaining complex deviations/production discrepancies.
Demonstrated initiative and attention to detail with proven organization skills
Demonstrated ability to multitask and meet deadlines.
Ability to work independently and as part of a team in a very busy and fast-moving working environment.
Ability to contribute to cross-functional teams while providing independent judgment regarding compliance issues.
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.
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