Title: Quality and Compliance Manager
Essential Duties and Responsibilities:
· Accountable for the successful development, deployment and implementation of Supplier Quality Management and New Product Introduction strategies and associated policies, procedures, programs and initiatives that deliver quality/compliance, cost and/or operating benefit to the supply chain
· Position actively works with suppliers and senior-level management to review on-going performance, to develop and implement quality systems, processes and procedures, and to identify and drive improvement activities
· Monitor the internal/external environment for changes and trends and assess the impact on projects and suppliers
· Provide leadership within the Organization, mentor and develop members to adhere to strict compliance with procedures and exercise the highest level of integrity in the tasks performed in a timely and prompt manner
· Review and approval of Deviation reports, ensuring that procedures are followed for documenting and investigating deviations to determine root cause and implement effective CA/PA
· Review and approval of Change Controls for production processes and equipment, ensuring that procedures are followed and changes are documented, approved and assessed appropriately
· Acting as primary customer QA contact for products. Leading QA meetings with the customer, notifying customers of deviations and changes, and following up on customer requests to provide a high quality of customer service
· Supporting product release activities by timely review and closure of deviations and change control assessments
· Maintaining required training compliance for procedures assigned for position.
· Perform on-going cGMP training of employees through the current training program. This will include presenting cGMP training material to new or current employees upon request
· Providing monthly summary reports to Supervisor/Manager, as requested
· Participation in Customer and/or Regulatory Audits and Inspections, as needed
Qualifications:
· Excellent written and verbal communication skills
· Must have attention to detail and good investigation, problem solving and organizational skills
· Ability to work effectively with people and communicate information to obtain positive results
· Works well with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively
· Listens and is attentive to others
· Must have excellent computer skills including Microsoft applications (Word, Excel, Access, PowerPoint)
· Capable of taking direction and completing assigned tasks on-time
· Able to manage time efficiently and adjust to changing priorities quickly
· Must be a strong, dependable team player
· Independent and capable of efficient time management with minimal supervision
Complexity of Work: The ideal candidate will be deadline focused, detail oriented, well organized and self-motivated along with the ability to juggle multiple projects simultaneously and manage time efficiently.
Education: Life Science (or related) Degree a plus.
Travel: As necessary.
Experience required: Strong understanding of cGMP compliance regulations and ability apply regulations consistently.
Benefits:
Group Medical and Dental Plan
401K with Company Match
Paid Holidays
Paid Vacation Plan
Relaxed/Casual work environment (not sure if that is the exact language to use, but something to describe we are not corporate and stuffy)
Bonus Structure