Summary This position is expected to be the QA - Operations Lead for the entire site. As a leader for the site, this individual will exhibit leadership traits and characteristics and be perceived by not only his/her group as a leader, but also by the site when Quality Assurance - Operations issues arise around the site. This will be accomplished by ensuring the following responsibilities are met, and by ensuring a strong Quality culture is maintained throughout the Operational portions of the facility in cooperation with the aims and direction of the Site Quality Head.
Oversees, manages, and ensures the successful day-to-day operations of Quality Assurance - Operations departments for the company. The Sr. Manager, QA ensures this success of the teams by oversight of the Managers (or possibly Managers and Supervisors) of the functional groups. Direct management of the individual contributors may occur on a limited basis as well.
- The first goal of all Patheon - St. Louis employees is safety. The Sr. Manager of QA is responsible for ensuring this safety message is implemented and lived throughout their organization and bolster this throughout the facility as possible.
- Ensure the QA - Operations groups successfully ensure the quality of all GMP manufacturing activities, executing manufacturing and QC records in accordance with specified timelines. Continually seek ways to improve the Quality Culture of the facility and specifically of Operations, the quality of work performed by Operational and QA - Operations functions, and to improve efficiencies throughout QA - Operations in regards to these tasks.
- Ensure the QA - Operations groups successfully perform batch disposition activities to meet specified timelines. Ensure the batch disposition process is robust and continually seek ways to improve the disposition process both in terms of effort expended, timeliness of disposition, and quality of work performed/quality of the disposition.
- Ensure the resources utilized throughout the QA - Operations organizations are appropriate for the tasks assigned, and ensure the GMP requirement for appropriate staffing levels in all Operational aspects of the facility is continually met while simultaneously supporting efficiency improvements that reduce the amount of work/time expended on specific tasks.
- Ensure the timely review of batch records, SOPs, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements.
- Establish meaningful goals and metrics for groups in conjunction with the Site Head of Quality, and manage the performance to those goals.
The Sr. Manager of QA will also interface with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required by the QA staff. The Sr. Manager of QA will also be required to ensure quality and compliance are maintained in the face of customer challenges to internal decision making, and to be able to effectively communicate and work with customers to resolve any disagreements that arise in this regard.
Coaching and mentoring to direct reports will be required on a regular basis. The Patheon - St. Louis site wishes to ensure a premium is placed on its people and their development. This will involve coaching to success on annual goals, and ensuring direct reports are maintaining high quality, high performing teams. This will also involve providing personnel development to ensure careers in the organization flourish. The annual goals will be derived from the annual goals delivered to the Sr. Manager - QA from the Site Head of Quality, and will be performed in support of the site, business unit, and corporate quality objectives. The Sr. Manager must ensure that the same levels of coaching and career support are being brought by his/her direct reports to the members of the overall organization. As the only good feedback is honest feedback, all coaching and mentoring will be supported by 360 evaluations as appropriate, and feedback must consist of both positives and negatives to support growth of the employees.
- Ensuring the quality and compliant production and disposition of batches and the quality and compliant operation of all systems throughout the facility in accordance with schedule requirements.
- Communicating priorities and distributing work assignments to direct reports. Ensuring that all work performed by staff is performed safely, with quality, and in a timely, compliant manner.
- Leading and ensuring the group is leading and participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all QA systems and processes as well as those on the floor through the QACI function.
- Leading, managing and/or participating in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. Ensuring the group is doing the same as required.
- Managing professionals within Quality Assurance Operations. Hiring employees within the QA OPS department with appropriate skill sets to perform tasks required of direct reports and ensuring direct reports are doing the same for their portions of the organization. Providing feedback and coaching in technical skill development, job performance, and career growth, and taking necessary disciplinary actions if necessary. Advocating for employees when required.
- Ensuring and participating in the QA support to internal manufacturing and technical groups. Coordinating special projects within functional areas and assigning resources as appropriate.
- Ensuring adequate training (skills-based, cGMP and Safety) of associates within department, to support GMP production through highly competent staff. Improving training for staff.
REPORTING RELATIONSHIPS: Typically directly manages 3-5 employees with additional indirect oversight of approximately 15 - 25 personnel.
EDUCATION AND QUALIFICATIONS:
- Bachelor’s Degree in Life Sciences or Chemical/Biochemicalengineering.
- 10+ years of experience in a GMP environment (QA, QC, manufacturing).
- Extensive knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and otherinternational guidelines to all aspects of the position.
- 4+ years of prior successful experience in a Manager role is required.
- Technical knowledge of (bio)pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable
- Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make key decisions.
- Proficient with computer (MS Office) and internet skills. Working knowledge of controlled documentation and data systems.
- Continuous improvement mindset.
- Assertive, not aggressive, assurance of quality throughout all operations within the facility. The ability to constructively work with colleagues when a Quality concern is in conflict with short-term business desires to successfully conclude the issue at hand to the best business advantage (both short- and long-term) without sacrificing the quality of work or the Quality Culture at the facility.
- Extensive knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Applies GMP regulations and otherinternational guidelines to all aspects of the position.
- Provides overall departmental feedback to Site Quality Head.
- Able to work with the goals and objectives of the Site Quality Head and translate them into actionable work for staff to meet those goals and objectives.
- Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
- Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
- Actively takes the lead in ensuring GMP compliance for the company. Sets strategy in investigations and CAPAs, as necessary. Ensures follow up.
- Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
- Participates and/or leads meetings, to provide input on timelines, potential compliance issues and other related QA activities.
- Able to indirectly manage performance of people through direct reports.