Job Title: Manufacturing Compliance Manager

Reports To: Director of Manufacturing

Department: Manufacturing

Classification: Exempt, Full Time

JOB SUMMARY:

The Manufacturing Compliance Manager (MCM) will effectively manage compliance with quality and regulatory standards applicable to Pharmgate Omaha Manufacturing Operations. The Manager will develop and implement processes, procedures, and policies to meet all quality standards. This position assures efficient manufacturing by gathering and presenting data that reflects compliant production operations, authors deviation and investigation reports when there are atypical events. The MCM will be monitoring and analyzing data to identify trends and make recommendations for improvement.  

LEADERSHIP RESPONSIBILITIES:

1. Leads with influence across the manufacturing departments to support the Director in compliance with cGMPs as related to manufacturing operations. 
2. Is informed and endorses the daily workflow and schedules of the department.
3. Conducts timely and constructive operational performance evaluations.  
4. Provides routine Key Performance Indicator (KPI) snapshots and reports of compliance status.
5. Provides technical writing authoring and guidance within the department for deviations, investigations, IQ/OQ, and change controls as required.

DUTIES/RESPONSIBILIITIES:

1. Assure manufacturing operates in accordance with FDA current Good Manufacturing Practice (GMP) requirements and guidelines. 
2. Maintain Pharmgate Standard Operating Procedures (SOPs) by utilizing your professional background and accepted industry procedures and techniques in line with company policy requirements.
3. Interpret analytical findings to assess compliance or non-compliance with company and industry standards. Report documented findings to department director or production management and escalate atypical results as needed.
4. Completes company required forms in connection with project assignments. 
5. Tracks non-compliance with granularity in regard to equipment, personnel operators, documents and training for compliance with SOPs and other records. 
6. Provides non-compliance reports of operators and subordinates to area department leadership.  
7. Develop a robust system for real-time batch record review with Manufacturing Quality and refers corrections back to subordinates for real-time and accurate edits/corrections.
8. Ensures compliance with federal, state, local, FDA, cGMPs organizational laws, regulations, guidelines, and best practices.
9. Provide immediate awareness to the Manufacturing Director regarding safety compliance to ensure a safe work environment.
10. Participate in team meetings as needed.
11. Contribute to department efforts in strategic planning, talent development, and training. 
12. Responsible for timely investigation and deviation writing and editing, CAPA development and reporting results of analytical testing in compliance with quality management systems.
13. Performs technical writing and other duties as assigned.

REQUIRED SKILLS/ABILITIES:

1. Thorough knowledge of cGMP manufacturing terminology, methods, and tools.
2. Working knowledge of Regulatory, cGMP and FDA regulations as required to ensure Pharmgate products and production units meet internal and external quality standards.
3. Ability to work collaboratively and communicate effectively.
4. Valid driver’s license. 
5. Strong analytical skills, verbal and written communication abilities.
6. Utilizes organizational skills and time management and so effectively manages multiple priorities daily.
7. Proficient with Microsoft Office Suite, such as basic Excel® spreadsheet functions and MS-WORD®, word processing.

PREFERRED SKILLS/ABILITIES:

1. Proficient with virtual meeting applications, SAP Business One, or other related software.

EDUCATION AND EXPERIENCE:

1. Bachelor of Science degree in Chemistry, Microbiology or Biology or related field.
2. Minimum five (5) years’ experience in a cGMP manufacturing setting with an emphasis on quality focus experience; preferably in a pharmaceutical production facility.

PHYSICAL REQUIREMENTS:

1. Prolonged periods of standing and walking through the facility.
2. Prolonged periods of sitting at a desk working on computers.
3. Must be able to occasionally lift 45 pounds from floor to waist level.
4. Visual acuity to inspect products and machinery.
5. Ability to occasionally climb stairs.

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.