Works independently to provide leadership and oversight to junior QA team members as they provide QA oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality and laboratories. Utilizing a wealth of previous experience provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet BIFI and regulatory standards. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas. Responsible for mentoring, coaching, may act as a delegate to sign official documentation in the place of management, and makes difficult decisions with little time for deliberation that can have a direct impact on active manufacturing operations, the release of equipment or area, or product release. Implements continuous improvement efforts as it relates to QA activities. Indirectly leads others within the QA Team under the leadership of the area head. Fosters quality collaboration among the site and QA staff. 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:
- Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to all GMP areas (i.e. MFG, E&T, QC, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business including the on-going training of junior team members.
- Independently serves as QA representative in decision making and conflict resolution with junior team members as needed in the absence of the department head.
- Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
- Authorized to suspend any operation when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues utilizing independent judgment and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the Sr. QA Specialist to utilize the input of others to make a final compliance determination. .
- May also be required to communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures.
- Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Sought after by junior team members for guidance in the quality oversight of changes within the Quality Management System including appropriate stakeholder’s reviews are completed such as Regulatory, Client, Area Managers, etc.
- Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and Approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.
- Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems. May be a certified Green-Belt and assigned to lead process improvement initiatives via the BPE program. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements.
- Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
- Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
- Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business.
- Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.
- Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of level. Will provide input on the performance of junior team members to the department head as part of the performance management process.
- Requires a Bachelor's Degree in Microbiology, Biology, Chemistry (Or closely related degree with these core courses as the foundation)
- Requires eight (8) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas.
- Strong independent judgment and decision making abilities required.
- Experience leading people and/or projects with history of achieving results and outstanding outcomes.
- Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
- Proven project-management skills required. Must be able to manage multiple projects against given time-lines.
- Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred.
- Independent decision making capability and ability to think conceptually and understand impact of decisions critical
- Proven global problem-detection and problem-resolution skills required
- Possesses strong conflict resolution and negotiation skills
- Must be able to independently represent the department in a wide-assortment of situations
- Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
- Must possess excellent verbal and written communication skills; good interpersonal skills.
- Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds.
- Emerging leadership and mentoring experience required. Must be able to indirectly lead others on the assigned floor / shift in the absence of the department head.
- Ability to work independently.
- Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
- Visual Demands - Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color-blindness.
- Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
- Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older