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. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.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.
Understands 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.
Manages document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as, regulatory requirements.
Establishes and maintains 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. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.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. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.personal initiative. dynamic pace. meaningful work.Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .