Manager- Manufacturing Compliance

JOB SUMMARY

The Manufacturing Compliance Manager is responsible for managing a team of technical writers with responsibilities encompassing GMP activities within the Manufacturing, Technical Operations, and Quality departments.

Primary duties include:

Writing/Managing/overseeing deviations/CAPAs/GMP documentation to ensure they are routinely addressed/closed in a timely manner including on-time batch release

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.

WHAT YOU WILL DO

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.

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

Will serve as process owner to promote engagement/accountability 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.

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 management's assignment of essential functions.

This is an exempt (salary) position.

Sound understanding of the 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 There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.

HOW YOU WILL GET HERE?

EDUCATION/EXPERIENCE

• Bachelor’s degree in Sciences, Engineering, or related field with 7 years of industry experience in Operations/Compliance.

Knowledge, Skills, Abilities

• Ability to write technical concepts clearly and concisely with good punctuation and grammar to enable clients to effectively analyze product impact.
• Experience in Microsoft Suite (i.e., Excel, Word, PowerPoint).
• Ability to read and interpret GMP and other regulatory requirements.
• Ability to work effectively and accurately in a fast-paced environment.
• Skills to define problems, collect data, establish facts, and draw valid conclusions.
• Experience with performing Root Cause Analysis techniques to describe and determine the root cause and critical contributing factors to the event.
• Coordinate with subject matter authorities to identify and document actions that will minimize the risk of a repeat occurrence of the event.
• Effectively interact with internal contacts at all levels company-wide (IT, QA, Operations, Client Services, Supply Chain, etc.). Limited contact with external customers.
• Must have the ability to effectively present information and respond to questions from senior management, peers, and clients.

Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.