Document Control Manager

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:The Document Control Manager will oversee Document Control activities in both the Owings Mills and Chesterbrook sites. Prioritize both routine and special project assignments for both locations. Create and/or optimize Document Control procedures that ensure compliance per FDA regulations while maintaining system efficiencies. Audit activities for adherence to applicable procedures to maintain Regulatory compliance. Represent Document Control in interdepartmental interactions and support quality assurance efforts at both locations. Lead a team of Document Control personnel. Manage document change control activities (including data tracking systems and electronic templates) and summarize in a monthly report to the Critical Documentation Senior Manager. Provide status reports on documents that are being developed/revised. ? Manages the day-to-day activities of the Document Control group.? Assesses quality implications, appropriateness of activities and decides on relevant actions.? Summarizes the document control activities in a monthly report to the Critical Documentation Senior Manager. ? Review and approval of Quality Notifications (QNs) related to Document Control.? Support of Quality Assurance efforts at both locations.? Ensures adherence within the Document Control group to all approved SOPs.? Effectively communicate and affect resolution with other departments within Shire as relevant to Document Control issues.? Participate in meetings and provide guidance on QA Document Control issues.? Generate regular metrics reports to management on systems to include, but not limited to: standard operating procedures, protocols, QNs, and standard forms.? Revise or implement systems to stay current with changes to the CFR or FDA guidance documents. ? Assist in all FDA inspections regarding Shire marketed products.? Work under challenging deadlines and be accountable for completing work within specified time periods.? Comply with company procedural guidelines, SOPs and safety procedures.? Organize training and cross training requirements for direct reports.? Contribute to a team oriented, continuous improvement quality process.? Demonstrate the Shire values on an ongoing basis.? Train, develop and manage direct reports. Meet periodically with direct reports to discuss ongoing performance and project related items.? Other duties as assigned by management.? Interacts and is accountable to various functional groups across the company to include production, technical services, facilities, quality assurance, quality control, and materials management.Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? BS in appropriate discipline.? Minimum of 5-7 years experience in Quality Assurance and applicable experience? Ability to speak effectively and communicate directly with all levels of personnel in the company.? Ability to write routine reports and correspondence for internal/external customer communications. ? Excellent attention to detail, work processing accuracy.? Strong organization, prioritization, and problem-solving skills.? Strong self-motivation and able to work independently.? Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment.? Exhibit strong knowledge of cGMP regulations.? Exhibit strong leadership and communication abilities.? Exhibit ability to interpret SOPs and regulatory guidance?s and documents.? Demonstrate ability to make timely and accurate decisions relating to Document Control.? Provide input to other functional groups regarding Document Control practices and requirements.? Prioritize workload to meet production demands on a daily basis.? Keep Sr. Management informed of potential conflicts and issues as needed.? Proactive in evaluating resources to meet company and interdepartmental goals.*Frequent travel required between Owings Mills, MD and Wayne, PA locations.Apply to Shire