Manager Cell Culture Technology Center Quality Assurance Systems
Your tasks and responsibilities
The primary responsibilities of this role, Manager CCTC QA Systems, are to:
- Provide quality oversight to the project team. Execute the project to plan. Closely work with all functional areas to ensure timelines are met safely and compliantly. Challenge assumptions appropriately. Review and Approve project documentation (URS, FS, FAT, SAT, IOQ protocols etc) to meet required timelines.
- Author, review or approve manufacturing documentation required for the project (SOP, BPR, Process descriptions, Risk assessments). Ensure adherence to platform process but with strong focus on flexibility and adaptability.
- Build high performing team. Ensure timely onboarding of personnel to maximize training opportunities and to support all process and / or facility validation requirements (FAT, SAT, IOQ, PQ). Build team culture that is strictly aligned to LIFE values.
- Work with the site team to establish robust processes for integration of CCTC with existing site systems e.g. QA documentation, change management through BASICS, deviation and CAPA management in Dev@Com.
- Support tech transfer of new product(s) in parallel with project and ensure GMP readiness to manufacture on time.
- Manage daily manufacturing activities to meet production plan
- Leads a functional group to assure that deviations are investigated in a compliant and timely manner.
- Performs analysis of multiple deviation reviews requiring evaluation of complex multi-variant data to ensure patient safety, product quality and conformance to all regulatory agency requirements;
- Leads a functional group to assure that change applications are completed in a compliant and timely manner
- Acts as a technical resource to support review of change applications.
- Identifies and escalates product quality issues to senior Quality management.
- Establish and maintain departmental metrics for area (weekly, monthly, and annually). Support release cycle time targets.
- Ensure timely review of manufacturing documentation with focus on GDP and compliance.
- Provides oversight and management of compliance management system applicable to CCTC.
- Represents QA during audits and provides audit responses to observations.
- Ensures materials and suppliers are qualified.
- Provides effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives
- Coordinate with operations and supply chain to adhere to clinical and launch targets – meeting or exceeding monthly and annual production output demand
- Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives.
- Encourage an environment of continuous process improvement and take action accordingly.
- Work cross functionally to develop an efficient and compliant process and, if needed, multi-product manufacturing in a single use facility.
- Support validation in commissioning and IOPQ of new equipment when needed (e.g. tech transfers).
- Actively manage department cost center by reviewing monthly costs; look for opportunities to reduce costs and to operate more efficiently. Prepare and adhere to production output and operating budgets for department. Exert proper control and managing of expenses and use of resources, scraps, invoices etc.
- Provide off-hour quality support and on-call emergency response when required. Must be able to work an off shift schedule as needed, including weekend cover.
- Manage Change Applications process within CCTC to ensure timely and compliant changes.
- Manage the Deviation and CAPA system within CCTC.
- Ensure Production areas and processes are maintained in excellent cGMPconditions at all times. Ensure that all compliance commitments are met
- Ensure the plant, processes and personnel are inspection ready at all times and prepare the plant for inspection by external authorities and internal audits. Drive Quality mindset through ownership and self-assessments
- Seek opportunities for improving overall compliance and discrepancies. Track deviation generation in the department and ensure that adverse trends are addressed quickly and effectively. Lead and / or participate in investigations to resolve deviations. Partner with Quality unit and engineering representatives to determine root causes of discrepancies and write-offs and implement effective corrective actions to minimize reoccurrence.
- Assess process impact of proposed changes in materials, equipment and provide decision making recommendations for changes.
- Provide effective leadership including: individual goal setting/performance reviews, training, coaching, and managing the development of employees; ensure appropriate staffing levels are met; effectively manage employee performance issues and corrective actions, recognizing and appreciating employee contributions, mitigating conflict and communication problem; planning and facilitating team activities; selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives
- Create and maintain the structure for staff meetings, daily meetings and floor shift huddles. Ensure standardized agenda, flow or relevant information/ data from one level of meeting to the next.
- Develop and adhere to standard work practices to
improve operational efficiency and communication.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- BS with 8+ Years of industry experience, or MS with 2+ Years of industry experience, or PhD with no prior industry experience, or Equivalent combination of education and experience.
- 1-2 years of line management
- Broad knowledge & expertise in some or all of the following manufacturing areas: Cell Expansion, Cell Culture, Purification, Media & Solution Preparation and Weigh/Dispense. Proven ability to partner to resolve issues.
- Experience with regulatory and cGMP requirements for pharmaceutical manufacturing. Solid knowledge of pre and post-viral segregation requirements. Knowledge of applicable agency regulation (FDA, EMA etc) to ensure inspection readiness of department.
- Solid understanding of Quality Assurance topics relating to: qualification and validation, deviation management, change management, compliance management system requirements, material qualification and release, and auditing.
- Experience with single use technology and mAb production desirable.
- Previous experience in technology transfers or New Product Introduction desired.
- Thorough understanding of department & business processes. Ability to write or follow written standard operating procedures, good manufacturing practices, safety regulations, and corporate policies.
- Must be able to work in an independent manner and drive the work of others.
- Experienced with business systems such as SAP, LMS, MES, Dev@Com (DR/CAPA System), Valgenesis, BASICS, etc. Experienced with Microsoft Office, Outlook, Visio, Microsoft project, and web search engines. Excellent computer skills.
- Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams.
- Acts as a mentor and provides leadership for direct reports. Ability to develop appropriate people skills to motivate, teach, and encourage staff. Recognizes the strengths and development needs of others, provides formal and informal feedback, and creates development opportunities for direct reports.
- Acts as a change agent and applies effective change management.
- Assists in providing leadership, strategic direction, and goal setting for all department activities. Acts as delegate to CCTC Plant Production Lead if needed.
- Demonstrates a clear bias for action. Promotes a sense of urgency and establishes and enforces individual accountability in the team. Delivers on commitments. Anticipates problems, develops contingency plans to achieve results. Persists in the face of challenges and setbacks. Consistently follows through.
- Demonstrates composure under pressure and maintains positive outlook. Demonstrates appropriate level of adaptability and flexibility. Makes logical decisions under pressure and with limited information available. Clearly articulates decision making processes.
- Challenges the status quo and embraces change. Adapts easily to meet business needs. Actively looks for opportunities to improve and
- encourages same of others. Works easily with limited information. Drives improvement opportunities through to fruition.
- Promotes ideas and proposals persuasively. Excellent influencing skills. Establishes open, candid, and trusting relationships. Demonstrates integrity by standing by decisions. Shows consistency between words and action.
- Defines success in terms of the team. Establishes common objectives and a shared mindset. Provides direction to direct reports towards achieving department goals and objectives. Empowers others by appropriately pushing decision making and responsibilities down. Creates a strong team morale. Rewards team efforts. Fosters open and transparent communication within the team and department. Puts a high priority on developing others through coaching, feedback, exposure and stretch assignments.
- Treats colleagues from all levels as internal customers. Interacts and responds to requests respectively. Gains insight into customer needs. Represents own interests while being fair to others and their areas. Partners to get work done. Credits others for their contributions and accomplishments.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Functional Area: [sap_fa_20]
Entry Level: 5