Associate Director, Quality Systems
Boehringer Ingelheim Animal Health USA
1,796 reviews
1730 Olympic Dr, Athens, GA 30601
Full-time
Boehringer Ingelheim Animal Health USA
1,796 reviews
Read what people are saying about working here.
Job details Here’s how the job details align with your job preferences. Manage job preferences anytime in your profile .
Job Type
Full-time
This position is a leader in the Quality Systems ' Compliance (QS'C) Team and oversees quality management team, comprised of management level staff, to provide appropriate oversight of assigned Quality Systems. Partners with colleagues for strategic planning of Quality and cross-functional issues and initiatives (colleagues in Quality Systems ' Compliance Management Team include Head of Compliance, Head of Supplier Quality, other leaders with assigned key quality systems).Responsible for implementation of new quality system regulations and/or corporate requirements and represents the department as member of cross-site/functional project team by providing guidance, insight and recommendations relative to the goals and objectives of the site/department.Associate Director level QS'C leaders are accountable for a combination of quality systems and lead management level personnel with local and/or global responsibility for quality systems. Quality Systems within the scope of the role (either directly or indirectly) include the following:
• GMP Training
• Records Management
• Change Control
• Document Management
• Data Integrity
• Quality Risk Management
• Inspection Readiness
• Quality Management Review/Quality Governance
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
• Accountable for the programs and processes related to assigned Quality Systems, including:
• Serves as Local/Divisional Management System Owner or oversees Local/Divisional MSO for assigned Quality Systems.
• Ensures assigned Quality Systems and processes are managed in compliance with regulatory requirements, with appropriate level of staffing and budget.
• Ensures sufficient resources to support needed process improvements and alignment of Local processes with Division or Global processes for assigned Quality Systems.
• Note: Responsibilities for oversight of additional Quality Systems not listed above may occur based on business needs.
• Ensures that assigned Quality Systems are inspection ready.
• Presents respective Quality Systems to auditors and inspectors, to prove the organizational compliance with relevant regulations.
• Actively participates in audits and inspection. Acts with heavy involvement in a minimum of 3 audits per year. Represents process during internal/corporate client audits and health authority inspections. Able to document, lead and coordinate commitments and associated corrective actions to health authorities, clients as well as corporate and internal auditors.
• Serves as the Sponsor during planning and implementation of improvement projects relating to assigned quality systems; provides communication of issues, project updates and changes to site management, stakeholders and users. Project scope may include representation on quality systems which are multi-disciplinary (cross functional, cross-divisional, cross-site).
• Ensures continued support for project operations (e.g. timely completion of Quality System records and reports).
• Ensures L/DMSO performs tasks associated with given deliverables for routine and / or adhoc activities.
• Documents use of resources and time allocation.
• Engages local, divisional and global network to ensure alignment with Boehringer Ingelheim standards and related operating units.
• Provides customer support to the site with respect to assigned Quality Systems.
• Influences local and divisional network based on knowledge and experience within Quality Systems.
• Provides guidance and support to L/DMSOs of assigned Quality Systems to ensure:
• Process and system training for site staff involved in Quality System processes, balancing training offerings with site demands.
• Training material is developed to ensure a high level of quality, compliance and consistency in execution of cGMP activities.
• System access to employees is controlled appropriately.
• Serves as a site Change Leader for new Quality System initiatives; identifies barriers to successful implementation and works to resolve them.
• Supports and improves Quality System and / or cross-functional Key Performance Indicators.
• Establishes, maintains and improves new and established network alignments (e.g. Corporate, Bio).
• Sponsors or leads local, divisional and global process improvement teams.
• Pro-actively engages the site to uncover issues and concerns relating to quality systems, and facilitates resolution and continuous improvement.
• Leads manager level staff and provides guidance and support to L/DMSOs who are held to the above responsibilities.
• Organizes and adapts department infrastructure to meet functional and site objectives, with focus on product quality and patient safety by:
• Hiring and developing talent to ensure support to commercialization and continuous improvement of the Quality Organization.
• Establishing cross-training activities and back-up efforts within assigned Quality Systems.
• Annually assessing group tasks and completes accurate resource planning.
Requirements
• Bachelors degree from an accredited institution, preferably in a science, engineering or business area. Requires ten (10) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas.
• Master's degree from an accredited institution preferably in a science, engineering or business area. Requires eight (8) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas.
• PhD degree from an accredited institution, preferably in a science, engineering or business area (such as arts and sciences). Requires five (5) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas.
• This position requires a person who is organized, hard working with a productive work ethic. The individual should be able to make sound decisions with an understanding of the impact of those decisions; an individual able to manage tasks and priorities in alignment with department and site drivers.
• The Quality Systems group has an emphasis on process development and optimization, not just system maintenance, therefore the employee must retain flexibility in problem-solving, providing risk-based options towards challenges which may require management review and decision making.
• Knowledge of where to go in the organization for needed information is critical; people leader roles must also have ability to judge what information should be passed on to different levels of management or organizational units.
• Experience leading multiple projects with history of achieving results against given timelines, occasionally in rapidly changing conditions is needed.
• A compliance mindset is critical. This individual should be able to communicate clearly and professionally both verbally and in written form. Strong conflict resolution and negotiation skills are needed, so a person with well developed interpersonal skills and the ability to establish highly functional relationships with diverse personalities both internal and external to the company is a must.
• Advanced knowledge of cGMP is a must, including knowledge of international regulations. This position will require the ability to interpret and relate quality standards for implementation.
• Must have a strong understanding of the regulatory requirements and compliance standards under which Boehringer Ingelheim Athens operates; since position may require direct participation in BI interactions with various government agencies / regulators as well as external auditors.
• Requires organizational balance, coordination and communication between multiple departments including Operations, Process Science, Quality as well as other functional and supporting function business areas.
• Position holder must balance a complex business / operational model with competing factors.
• Work is primarily located at the BI Athens site; however, interaction with colleagues at other sites may be required nationally and internationally.
• To quality for this position, the following criteria must be met:
• Employed must be able to travel nationally and internationally.
• Strict performance of techniques as trained, compliance to documentation practices and other cGMP requirements.
Desired Skills, Experience and Abilities
You must create an Indeed account before continuing to the company website to apply
Apply now
save-icon
Report job