Janssen Global Services, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Regulatory Compliance Manager (DEA), located in Vacaville, CA.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information
The Manager, Regulatory Compliance will manage the Controlled Substance (CS) programs and support Good Manufacturing Compliance (GMP) Compliance programs to assure compliance to regulations, as well as Janssen/Alza policies and procedures. The primary responsibility of this position is to lead various CS activities to maintain a consistent and high level of compliance to Drug Enforcement Agency (DEA) regulations. This role will also support compliance to Heath Authority regulations as needed. Compliance to both CS and Heath Authority regulations includes: interpreting federal and local regulations, providing technical support for operations, process, practices and procedures and maintaining and submitting documentation and communication to regulatory agencies.
Principal Duties and Responsibilities:
Manage audits and inspections:
- Audit facility to ensure regulatory compliance.
- Lead Controlled Substance Compliance regulatory audits and inspections.
- Assist in the management of regulatory compliance and partner audits.
- Track, manage, and approve investigations, Corrective Actions/Preventative Actions (CAPAs), and audit responses.
- Perform internal audits, site walk-throughs and inspection readiness activities to verify compliance.
Oversee site process and systems:
- Interpret local and global regulations and ensure plant processes are in alignment.
- Support gap assessment evaluation for regulatory changes and ensure mitigation plans are developed and carried out to maintain site compliance.
- Provide oversight of controlled substance practices and procedure.
- Approve change controls and master data requests on behalf of DEA compliance.
- Review and approve deviations as they relate to DEA activities.
- Perform controlled substance compliance training to on-site personnel.
- Partner with site Security to maintain controlled substance requirements.
Manage Regulatory Reporting activities:
- Manage requests related to compliance, regulatory submissions, licenses, renewals.
- Liaison with DEA or other regulatory agencies as needed to support reporting requirements or requesting updates on permits, submissions, etc.
- Compile and submit information from various departments to complete required DEA reports (ARCOS, opiate, import/export, biennial and year-end).
- Maintain import/export permits. Submits monthly permit information.
- Maintain product licensing and renewal processes.
- Process, review, separate and distribute DEA 222 forms.
Material Management and Metrics:
- Review, collect and compile drug reconciliation information.
- Provide accountability and inventory information to support quota submissions.
- Monitor and report quota inventory consumption status.
- Participate in the year-end physical count and compiles reconciled data.
- Compile data to support monthly department metrics.
- A minimum of a High School diploma is required. Bachelor’s degree or equivalent preferred.
- A minimum of 8 years of related experience and/or training, or equivalent combination of education and experience, is required.
- Experience working in a regulated GMP environment is required.
- Prior experience and knowledge of controlled substance regulations is preferred.
- Previous experience communicating across all levels of an organization is preferred.
- Previous auditing experience is required.
- Familiarity with Quality System Regulations is required.
- Previous experience managing investigations is required.
- Previous experience resolving CAPAs required.
- Previous exposure to DEA audits is preferred.
- Previous experience with notified body audits is strongly preferred.
- This position is located in Vacaville, CA and may require minimal travel.
Alza Corporation (6002)Job Function