Sr. Manager QA Operations
$140000 to $165000 Per Year
Sr. Manager Quality Assurance Operations-St. Louis MO
- Bachelor’s degree in a Science Discipline, Master’s degree preferred.
- 10+ years of experience in a GMP environment
- 4+ years of prior successful experience in a manager role is required.
- Executing in a contract manufacturing environment or managing contract businesses
- Extensive knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
- 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 conflicts 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 other international 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).
- Able to indirectly manage performance of people through direct reports.
- Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
- Oversees, manages, and ensures the successful day-to-day operations of Quality Assurance - Operations departments for the company.
- Ensures this success of the teams by oversight of the Managers (or possibly Managers and Supervisors) of the functional groups.
- Ensure the QA - Operations groups successfully perform batch disposition activities to meet specified timelines.
- 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
- Interfacing with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required by the QA staff.
- 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 QA on the Floor 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.
- 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 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.
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.
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