1. JOB SUMMARY

The Production Compliance Manager is responsible for managing a team of associates with responsibilities encompassing GMP activities within the Manufacturing, Technical Operations, and Quality Control departments.  Primary duties include: 1) Managing/overseeing deviations/CAPAs to ensure they are routinely addressed/closed in a timely manner including on-time batch release 2) Managing/tracking GMP documents (batch records, SOPs, change controls, and other pertinent GMP documents) based on routine and non-routine activities including generation of new documents, revision and approval of documents. 

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

1. Oversee and manage deviations/CAPAs metrics associated with primary responsibility for manufacturing and as needed support for Technical Operation and Quality Control department:

• Individual will manage deviation Technical Writers and collaborate with SMEs and/or Quality to ensure timely initiation, review and approval of all deviations/CAPAs. Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure.
• The individual will utilize effective root cause analysis techniques during the investigation process and work cross functionally to help implement effective preventative actions and perform thorough product impact analysis.  
• Individual will be the SME for defending relevant deviations in GMP audits (internal and external).  
• Individual will lead and coordinate efforts for continuous improvement in deviation reduction for the site. 
• Track and report status on KPIs relevant to deviations and ensure commitments to key stakeholders are met in a timely manner.
• Initiate tracking and follow up of more complex issues stemming from deviation investigations.

2. Manage and oversee all GMP documentation with primary responsibility for manufacturing and secondary to technical operation and quality control departments.

• Will serve as process owner to promote engagementccountability on manufacturing KPIs for GMP documentation (SOPs, batch records, change controls, CAPAs, etc.).      
• Author, resolve, review and approve SOPs, Change Controls, and other GMP documents necessary to support production needs.
• Lead and work with cross-functional teams.

3. Manage/lead/develop team of associates with strong emphasis on emergent core values on collaboration, accountability, and culture of excellence through safety and quality mindset

• Perform performance review for all direct reports.    
• Lead/develop/coach team members on career growth and site goals with emphasis on collaboration and accountability. 
• Build a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork).
• Ability to identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and employees.  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• This is an exempt (salary) position.
• Bachelors Degree in Science and/or related field with a minimum of 5 years of CGMP manufacturing in the biopharmaceutical/biotechnology discipline.  
• Minimum of 3-5 year of managerial experience with ability of overseeing personnel in a fast-paced environment
• Sound understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices (cGMPs), CAPA, CC and regulatory guidelines.
• Highly organized individual with strong attention to detail and great technical writing ability
• Good root cause analysis, troubleshooting, investigation, and communication skills, both written and verbal
• Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
• Ability to manage time and priorities effectively
• Ability to interface with others effectively at various levels in multiple departments, including customers
• Good interpersonal skills with ability to work well independently and in a team environment.   
• High level of computer literacy, including MS Word and Excel
• Ability to work extended and flexible hours (including weekends) when needed