This is an expert-level individual contributor role, responsible for establishing, maintaining and managing Quality Control processes at BI Fremont to achieve company goals and department objectives. Incumbent serves as the subject matter expert (serves as the site point of contact/process owner) for various Quality Control processes (For example, method validation, method transfer, Deviation/CAPA, Change Control, complex Laboratory investigations). Proactively leads initiatives to improve Quality Control systems in the organization, develops Standard Operating Procedures and Key Performance Indicators for the business, to facilitate quality compliance across the organization. The incumbent will also represent QC on cross functional teams and serve as the Analytical Sub-team leader for CMC programs.
Incumbent independently exercises judgment and discretion within defined practices and policies in selecting methods, techniques and evaluation criteria for resolving complex problems, where analysis of situations or data requires in-depth evaluation of various factors, and considerable judgment in resolving problems and making routine recommendations. Independently Managers QC Projects to on time completion.
Quality Control oversight responsibilities include ensuring adherence to cGMP requirements, all methods intended for GMP testing are scientifically sound and validated to demonstrate they are fit for use, proper change control, corrective action and preventive action plans, impact assessments for changes to equipment and processes, risk management, ensure documentation and investigations meet BIFI and regulatory standards. Provide guidance to Quality Control team members as they provide oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) and other non-GMP areas to provide guidance on regulated industry practices and documentation. Responsible for mentoring and coaching Staff. Fosters quality collaboration among the site and QC staff. Acts 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 and Quality operations.
Implements continuous improvement efforts as it relates to QC activities. Can lead or serve as key member of Quality Control teams, such as Analytical Sub-teams, Validation teams, Change Control, Deviations and CAPAs, and Inspectional Readiness Core Team. Attends cross-functional meetings as responsible Quality Control representative. Works with clients and external vendors to prepare for audits and inspections. Works with functional areas to provide audit responses and ensure inspection readiness. Attends cross-functional meetings as responsible Quality Control representative.
Ensures programs and processes are aligned with Corporate/Global BioPharma and maintained in accordance with cGMP/Quality/Compliance regulations.
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:
- Coaches and mentors departmental employees
- Leads coordination and communication between departments, across functions and across BI sites.
- Plans, organizes, and implements projects within specified objectives
- Provides guidance to all GMP areas (i.e. MFG, E&T, PS, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified.
- Ensures staff are properly trained
- Develop Key Performance Indicators for the business.
- Responsible for both executing the tactical operations and overseeing QC team members. Leads/participates in investigations, solve technical problems and identify aberrant results to management. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner.
- Must be able to pro-actively identify issues to prevent missed timelines.
- Provides guidance to MFG, E&T, and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QC and the business including the on-going training of junior team members. Work with other QC groups to provide support, review of data, sharing of information/scheduling.
- Independently serves as QC representative in decision making and conflict resolution with junior team members as needed in the absence of the department head.
- Quality Control process improvement and implementation:
- Establishes Quality Control processes and systems according to corporate procedures and establish alignment with Biopharma network.
- Serves as the site Change Leader for new QC initiatives; identifies barriers to successful implementation and works to resolve them.
- Pro-actively engages the site to uncover issues and concerns relating to QC, and facilitates resolution and continuous improvement.
- Identifies and resolves critical issues (including deviations, investigations, OOS, etc.), as appropriate and typically works on complex Major issues. 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.
- Accountable for Test results. Provides guidance and control directives regarding remediation activities required to continue testing. Is required to resolve critical issues utilizing independent judgment and decision making as a senior member of the department. Serves as the final decision-maker utilizing the input of others to make a final compliance determination.
- Auditing and compliance:
- Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies. Prepares data and presentation for periodic management review for the site and QC functional areas. Conducts meetings, to ensure business remains compliant with all organizational standards and relevant regulations.
- Participates in inspection readiness activities. Presents QC review process, QC risk management program, deviation/CAPA and change controls to auditors and inspectors, to prove the organization's compliance with relevant regulations.
- Key Performance Indicator development and monitoring: Defines QC processes to be monitored, and establishes meaningful KPIs related to these processes.
- Collects quality data for Site BSC (Balanced Score Cards) and various Quality dashboards (e.g. Biopharma Quality Dashboard); defines KPIs to be reported and the intervals at which they will be measured.
- Serves as the Team Lead (project manager) during planning and implementation of improvement projects relating to QC KPI's; provides communication of issues, project updates and changes to site management, stakeholders and users. Represents QC on multi-disciplinary project teams.
- Applies project management skills and concepts to lead or manage projects with an interdisciplinary project team from planning stage to project completion.
- Trains Fremont employees on: QC risk assessments, Deviation/CAPA and Change Control systems. Develops training materials to ensure high level of quality and consistency for deviations/CAPAs and change controls.
- Requires a Bachelor's degree from an accredited institution in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation) with eight (8) years of pharmaceutical quality experience with Technical Leadership experience in QC and other cGMP areas or equivalent.
- Master’s degree from an accredited institution in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation)with six (6) years of pharmaceutical quality experience with Technical Leadership experience in QC and other cGMP areas or equivalent.
- PHD degree from an accredited institution in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation) with two (2) years of pharmaceutical quality experience with Technical Leadership experience in QC and other cGMP areas or equivalent.
- Requires two (2) years of Project Management experience with the ability to manage multiple projects as the same time.
- Virus testing and Virology industry experience is preferred in the required skills section.
- Thorough knowledge of GMP Pharmaceutical manufacturing.
- Work with autonomy and authority with the ability to make difficult decisions with little time for deliberation. Use of strong independent judgment and decision making abilities is required.
- Demonstrate troubleshooting and critical thinking skills.
- Highly productive, attention to detail, ability to manage time and prioritize tasks.
- Interface with other functional groups within and outside QC to request/share information, provide results and coordinate testing.
- 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.
- Independent decision making capability and ability to think conceptually and understand impact of decisions critical to product quality.
- Must be able to independently represent the department in a wide-assortment of situations
- Possesses excellent verbal and written communication skills; good interpersonal skills.
- Experienced in ensuring respectful interactions with individuals with diverse views or backgrounds.
- Developed leadership and mentoring experience desired. Must be able to indirectly lead others.
- Ability to work independently.
- Ability to work effectively on cross-functional and global teams.
- Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity.
- Participate in BI interactions with various governmental agencies/regulators and external auditors
- Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating
- Coordination and communication between multiple departments, including Manufacturing, Process Science, Quality and other functional areas.
- Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.
- To be qualified for this position must meet the following:
- Physical Demands / Surroundings - Requires physical activity such as being able to lift approximately 50 lbs.
- Visual Demands - Eyestrain associated with the use of computer terminals.
- Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has frequent contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
- Level of Proficiency - Experienced level subject matter proficiency required with technical expertise such that corrective actions resulting from procedural deviations are effective in a timely manner and that any changes to processes and procedures follow relevant change control procedures.
- Attendance / Schedule - The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
- To remain in this position, employees:
- Must obtain & maintain qualifications, as required, to perform the assigned work.
- Must understand, will be held accountable for and must adhere to all SOPs, company Policies and GMP requirements and Procedures
- Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
- Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.