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Quality Lead, External Compliance

📁
Supply
💼
United States
Thanks for your interest in the Quality Lead, External Compliance position. Unfortunately this position has been closed but you can search our 434 open jobs by clicking here.

 

A fantastic opportunity is available for a Quality Lead, External Compliance to join our Quality team.

  

 

Scope of Role

 

  • Maintain 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 Procurement, Quality Control and Factory Operations to resolve any issues with co-packers.
  • Propose quality improvements to co-packers and monitor implementation.
  • 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.

 Responsibilities

 

  • 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 (as necessary).
  • 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, including, active ingredient co-packers, raw material, component co-packers and finished products to RB Health.  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.
  • 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.

 Key Challenges

  • Approval of co-packers within required timescales.
  • Assure co-packers are compliant with GMP regulations and routinely deliver materials, components and products 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 prioritize 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 program by delivering robust justifications, which assure compliance and performance in line with RB policy and would withstand regulatory agency scrutiny.
  • Minimize regulatory adverse comment with regard to supply base.

 

Is this You?

 

  • Prefer BS/MS degree in a scientific or engineering discipline or equivalent.
  • 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 210/211 and 111, USP/EP Compendia and ISO 9001.
  • 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.


 

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.

 

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