Wayne Mish
Bustleton
Summary
Seasoned professional in DEA compliance, security management, and quality assurance with over 20 years of experience in the pharmaceutical industry. Expertise in implementing robust DEA programs, overseeing controlled-substance inventories and audits, and authoring comprehensive standard operating procedures (SOPs). Proven ability to manage security operations effectively while supporting cGMP investigations, complemented by strong skills in training, reporting, and cross-site coordination. Committed to enhancing operational integrity and regulatory compliance within dynamic environments.
Overview
25
25
years of professional experience
1
1
Certification
Work History
DEA Compliance Manager
Frontida/Adare Pharmaceuticals
05.2022 - Current
- Developed and manage DEA Compliance Program for North American sites (PA, IL, OH); maintain 7 DEA registrations.
- Prepare and submit DEA reports for Philadelphia site; coordinate monthly/year-end inventories and ARCOS where required.
- Create and maintain DEA-focused SOPs and training; audit departments for compliance.
- Implemented electronic controlled-substance inventory system (replacing paper) and trained staff.
- Advise on security operations and lead manufacturing uniform change to reduce security risks.
- Support onboarding of new clients/contracts with DEA compliance assessments.
DEA Compliance Specialist
Quva Pharma
06.2021 - 05.2022
- Assessed company readiness for DEA inspections; documented material and operational flows of controlled substances.
- Designed inventory spreadsheets to ensure integrity and ease ERP transition.
- Implemented reverse-distribution processes for controlled substances.
Documentation Specialist
Avet Pharmaceuticals
12.2020 - 05.2021
- Audited manufacturing batch records and supported ERP transactions for change controls and material movements.
- Ensured document compliance and accuracy of batch materials.
Manager, Corporate Security & Regulatory Affairs
PharMEDium Services / AmerisourceBergen
05.2019 - 06.2020
- Managed site security operations (scheduling, post orders, guard training) and coordinated outsourced security providers.
- Configured DEA-approved vault/cage alarms and monitored CCTV; led investigations into controlled-substance diversions.
- Oversaw DEA affairs: monthly ARCOS reports, controlled-substance inventories (~100k lots), access approvals, and inspections.
- Trained ~300 employees on handling and documentation of controlled substances; authored reports to DEA and NJ State Pharmacy Board.
- Led weekly DEA and EHS site inspections and supported EHS model development across sites.
DEA Compliance Specialist
Frontida Biopharm
10.2017 - 05.2019
- Submitted online ARCOS and quota applications; managed receipt and documentation of controlled substances and List I chemicals.
- Conducted internal self-audits, coordinated annual inventories, and represented company during regulatory inspections.
- Authored and maintained controlled-substance SOPs and trained personnel.
Senior Controlled Substances Coordinator / Site DEA Compliance Specialist
Actavis/Teva
12.2005 - 09.2016
- Managed controlled-substance monitoring, ARCOS reporting, SOMS review, and quota compliance.
- Coordinated reverse distribution and product transfers; led security procedures for DEA cages/vaults.
- Conducted annual internal audits and coordinated annual inventories; trained and supervised up to 20 warehouse staff handling DEA forms.
- Represented site during 42 DEA inspections with no observations or violations.
QA Senior Inspector / Trainer, In-Process Manufacturing
Andrx Pharmaceuticals
10.2001 - 12.2005
- Performed room/equipment/component releases, reconciled batch records, conducted in-process monitoring and AQL sampling.
- Trained and supervised QA inspectors on cGMP release procedures.
Education
Varsity Letter -
Port Jervis High School
Port Jervis, NYSkills
- DEA compliance management
- Managed controlled substance inventory
- SOP development and training
- Security operations management
- Audit and inspection coordination
- ERP inventory management
- Reverse distribution coordination
- EHS program assistance
- Training development
- Compliance monitoring
- Training and education
- SOP writing
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Documented and resolved diversion issues which led to robust security cameras and dedicated observers.
- Collaborated with team of 20 pharmaceutical manufacturing employees in the development of inventory integrity.
Certification
- Led 42 DEA inspections with no observations/violations (Actavis/Teva).
- 2019 PharMEDium Award — EHS model management.
- Multiple Best of Class / Excellence awards for DEA inspections and customer service.
- Certificate: Operational Excellence (OpEx); Certified Trainer in cGMP documentation and releases.
- US Air Force Security Police — Expert marksman (M-16, .38), Honorable Discharge.
Timeline
DEA Compliance Manager
Frontida/Adare Pharmaceuticals
05.2022 - Current
DEA Compliance Specialist
Quva Pharma
06.2021 - 05.2022
Documentation Specialist
Avet Pharmaceuticals
12.2020 - 05.2021
Manager, Corporate Security & Regulatory Affairs
PharMEDium Services / AmerisourceBergen
05.2019 - 06.2020
DEA Compliance Specialist
Frontida Biopharm
10.2017 - 05.2019
Senior Controlled Substances Coordinator / Site DEA Compliance Specialist
Actavis/Teva
12.2005 - 09.2016
QA Senior Inspector / Trainer, In-Process Manufacturing
Andrx Pharmaceuticals
10.2001 - 12.2005
Varsity Letter -
Port Jervis High School