Document Control Manager

Document Control Manager

INCOG Biopharma Services in Indianapolis, IN is hiring a Document Control Manager. Working closely with the Senior Manager of Quality Assurance, the Document Control Manager will be instrumental in developing and championing INCOG’s approach to the design, approachability, control, and training of content; ultimately being a major contributor for the Integrity of the management of data/information at the site. The Document Control Manager will manage the team responsible for the flow of documents, records, and subject matter experts, and own the logistical operations for all site inspections.

The Document Control Manager will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. They will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. Additionally, they will have strong familiarity with Microsoft word processing and spreadsheet management software. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.

The Doc Control Manager will have demonstrated leadership skills in the management of workflows of other teams and will have an understanding of the development of team goals, metrics, and culture. They will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes. They will have demonstrated working relationships with client and prospective client representatives and will have shown an appreciation for the sensitivity of confidential and proprietary information of both clients and the internal organization.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for their clients.

Essential Job Functions:

• Assume the role of INCOG Data Integrity SME and point of contact, alternate to the Sr. Manager.
• Administrate the routing, review, release, and retirement of controlled documents in an electronic document management system, including the periodic review of this program. Scope-out and plan and implement, in conjunction with the QMS Administrator, all eDMS functional advancement.
• Administrate the issuance, control, and reconciliation of a controlled copy and record program including Batch Records, Logbooks, Controlled execution forms, and stationed/posted materials.
• Maintain the design and perform the training of new employees on the requirements and significance of Good Documentation Practices, as well as controlled document and records management.
• Maintain site licensure documentation and coordinate renewal routing in conjunction with the QA Compliance department.
• Lead the logistics activities for client and health authority inspections, including maintaining documents, records, and other logistics in a state of continual inspection readiness.
• Organize and lead the Document Control Technicians and Specialists in their support of all applicable programs, provide them mentorship, and design and support their annual and career development goals.
• Plan and execute the outfitting of INCOG’s long-term Records Archive Room, including establishing and managing an offsite Records Management Program.

Special Job Requirements:

• Bachelor’s degree in a scientific or language/communications/data management field.
• 8 years’ experience in a regulated industry, 4 within the Pharmaceutical industry.
• 3 years’ experience as Administrator of an electronic Document Management System, experience in records management, i.e. issuance and reconciliation processes and storage controls.
• 6 years’ experience designing, writing, and/or editing documents of a technical nature.

Additional Preferences:

• Certification in Technical Writing or Information Management.
• Microsoft Office Manager or Expert certification in Word and/or Excel.
• Moderate to expert level experience with Microsoft PowerPoint, Visio and/or other presentation software packages.

INCOG’s Benefits:

• Paid time off, based on tenure.
• 11 observed holidays 1 floating holiday.
• Choice to elect for pet insurance.
• 401(k) plan with company match up to 3.5% of salary, vested immediately.
• Choice of health & wellness plans.
• FSA and HSA programs.
• Dental & vision care.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.