In this role, you will:

• Act as the subject matter expert on all FDA regulations and requirements as well as the advisor to the senior management team
• Act as liaison for all Regulatory agencies (FDA, EPA, DEA, CAL, DOJ & TTB)
• Spearhead the company's QA/QC functions while building a team of likeminded individuals
• Design and implement the Quality plan for the company including departmental goals, action plans, and budgets
• Develop Quality metrics and dashboards
• Drive continuous implementation of Lean, 5S, Value Stream Map and Kaizen
• Lead the development and implementation of a new, electronic QMS
• Act as the "go to" for audits and inspections (including readiness), as appropriate.
• Maintain SCM’s compliance with cGMPs
• Participate in the evaluation, selection service providers
• Create periodic reports to DEA
• Provide GMP, ISO, GDP training to the team
• Manage ISO 9001 certification for SCM
• Negotiate and maintain vendor Quality Agreements
• Provides guidance to peers regarding regulatory issues.
  Prepares and reviews annual reports and supplements for marketed products. The Director of Regulatory Affairs will Interface with Quality and Operations groups within the organization.
• Conducts label / artwork review.
• Accountable for Raw Material Change control program
• Support SCM’s Vendor Management initiative
• Develop lab resource plan to maximize QC lab test resources across all facilities reducing outside testing where appropriate.
• Oversee test method development activities working with Analytical for new QC lab test methods.
• Evaluate technologies that could increase cost savings, expand capabilities and improve testing accuracies as well as direct the development and validation of new test methods.
• Drive efficient manufacturing QC test sample processing to improve sample turn-around time
• Develop quality assurance and control staff by recruiting, selecting, orienting, and training and coaching employees.
• Review all QC testing data and related calculations. Maintain all paper and electronic documents and logs associated with QC testing.
• Issue Certificates of Analysis (CoA)
• Train and qualify laboratory personnel to perform their assigned laboratory duties. Manage inventory and order all supplies needed in QC.
• Maintain a full understanding of the Standard Operating Procedures (SOPs) and cGMP guidelines, applying them as required. Assist in the development and writing of SOPs, as necessary.
• Familiarity with 21 CFR Part 210 & 211 procedures.
• Solve problems by examining and evaluating data, as well as implementing corrective action when necessary.
• Enhance laboratory and organizational effectiveness by accepting responsibility for accomplishing laboratory operational goals and doing so with the highest quality and integrity.
• Responsible for third-party laboratories executing QC tests for SCM products.
• In charge of any deviations/investigations that may occur in QC.
• In charge of OOS investigations; Trending Environmental Monitoring data; Follow USP monographs and be up to date to new analytical techniques
• Supervises the identification and compilation of required documentation for submissions.
  Function as the regulatory and quality lead for any assigned projects; providing support to the Operation, Quality Assurance and Regulatory units as needed.
• Writes/review and update Standard Operating Procedures
• Independently prepares and submits meeting requests and meeting packages, leading all company quality and regulatory meetings.
• Provides expert opinion, advice, and recommendations to the organization regarding quality processes.

Experience/Education:

• Bachelor’s Degree from a 4-year accredited college with a Chemistry background
• Preferred Master’s Degree
• Minimum of 10 years managing dynamic QA/QC teams within a GMP environment (chemical and/or pharmaceutical research environment)
• Experience working with a government-regulated facility
• Must possess comprehensive technical knowledge in analytical science
• Must possess comprehensive knowledge and experience in GMP requirements
• Prior experience and knowledge in FDA GMPs (21 CFR Parts 210, 211, 820, and 600); ISO 9001 and 13485

  Language Skills:

  Ability to read, analyze and interpret common regulatory regulations and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies and/or internal team members. Ability to effectively present information and perform training to internal team members.

  Preferred Certifications/Licenses/Registrations:

  • LEAN Six Sigma Certification (preferred)
  • ISO 9001:2015 Lead-Auditor Accreditation
  • GMP Auditor