Manager, QA Document Control

Catalent Pharma Solutions; Harmans (MD); On-site; USD 118,000 - 164,000; Full time

Job summary

An established industry player is seeking a Manager for Document Control within its Quality Assurance group. This role is pivotal in managing the life cycle of controlled documents, ensuring compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will possess a strong background in life sciences, with significant experience in Quality Systems and Document Control. Join a dynamic and fast-paced environment that values employee engagement and offers competitive benefits, including medical coverage and generous PTO. This is an exciting opportunity to contribute to the development of life-saving products while advancing your career in a global leader in drug development.

Benefits

Competitive medical benefits

401K

152 hours PTO

8 Paid Holidays

Dynamic work environment

Continuous Improvement Processes

Qualifications

• 8-10 years in Quality Assurance with Document Control experience required.
• Proficient in GMPs, FDA regulations, and documentation procedures.

Responsibilities

• Manage Document Control operations and ensure compliance with GMP.
• Oversee daily activities and performance management of direct reports.
• Implement and enhance electronic Document Management Systems.

Skills

GMP knowledge

FDA regulations

Document Control processes

Performance Management

Conflict Management

Quality Systems knowledge

Education

Bachelor in Life Sciences

Master in Life Sciences

Tools

QDMS

LMS

EDMS

E-Doc

MS Office

Adobe Acrobat

Job description

The Manager, QA – Document Control is responsible for the overall leadership of the document control functions within the Quality Assurance group. The manager will manage the life cycle of controlled documents ensuring regulatory requirements are met and leading continuous improvement initiatives. The Document Control function supports both the GMP and development operations.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply.

The role:

• Manage the day to day operations in assigned area of Document Control.
• Ensure staff are fully trained on all Document Control processes.
• Build effective teams that apply their diverse skills and perspectives to achieve common goals.
• Drive engagement and create a culture where employees are motivated to do their best.
• Oversee daily activity for the group to ensure quality results Performance management for direct reports.
• Understand company goals and practices and apply them when resolving a variety of problems.
• Provide strategic oversight of the document control systems ensuring phase appropriate processes to support Phase I/II/III/commercial operations.
• Manage document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as regulatory requirements.
• Establish and maintain the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction.
• Define resource requirements, plans and prioritize resources, and manage personnel in daily duties and responsibilities based upon business and compliance requirements.
• Responsible for implementation, management, and enhancements of an electronic Document Management System (eDMS).

The candidate:

• Bachelor in a Life Sciences discipline with 8 – 10 years of experience within the life sciences or similar industry, preferably biotechnology or pharmaceuticals, performing within a Quality Systems/Quality Assurance/Quality Control role with some or all of that time responsible for Document Control activities.
• Masters’ in a Life Sciences discipline with 6 – 8 years of experience within the life sciences or similar industry, preferably biotechnology or pharmaceuticals, performing within a Quality Systems/Quality Assurance/Quality Control role with some or all of that time responsible for Document Control activities.
• 2 – 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
• Proficient knowledge of GMP’s, FDA regulations and documentation procedures required.
• Performance within a Quality Assurance role with some of that time responsible for Document Control activities preferred.
• Thorough knowledge of cGMP regulations, quality systems and regulatory requirements.
• Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc).
• Advanced skills with MS Office applications and Adobe Acrobat.

The anticipated salary range for this position in Maryland is $118,720 - $163,240 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

Why you should join Catalent:

• Competitive medical benefits and 401K.
• 152 hours PTO + 8 Paid Holidays.
• Dynamic, fast-paced work environment.
• Opportunity to work on Continuous Improvement Processes.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.