Sr. VP and General Manager

Sr. VP and General Manager

The Senior Vice President/General Manager is an integral part of the Civica, Inc. ("Civica") leadership team in establishing and building the site team and infrastructure. Responsibilities of the position include leading, directing and coordinating all operations at the Civica manufacturing site. This includes strategic vision and leadership in long-range planning as well as a focus on execution and team building to ensure compliance with Civica cultural tenets and sustainable and cost-effective manufacturing operations for the company.

Proven ability to cope with complexity, conflict, stress, and crisis situations through effective problem-solving and mediation skills. Champions a safe working environment and the supply of quality medicines with compliance to established policies, procedures, and guidelines.

The essential functions include, but are not limited to the following:

• Continue to build capabilities within the site leadership team.
• Provide overall site leadership and management to ensure that the mission, core values and culture of the Company are put into practice.
• Lead site team in oversight of detailed facility and equipment design, construction, process development and qualification, regulatory review and inspectional activities, product and site approvals, and implementation of commercial manufacturing in a cost-effective and time-efficient manner.
• Implement site operations strategy in alignment with company plans and member needs.
• Create and execute site policies and programs to maximize capacity and ensure quality supply and low costs.
• Assist in development of standard operating procedures and business processes for the site, including standard work, documentation, and tools to increase company efficiency and risk management.
• Provide vision and strategic input toward overall success of the site and the company.
• Lead site organization in establishing teamwork and morale.
• Establish performance and development plans for plant staff, consistent with a culture of individual and team accountability and high performance.
• Ensure that quality, regulatory compliance, and safety are key elements of the site culture.
• Assure interface and sound relationships with regulatory agencies like FDA, DEA, OSHA, EPA, etc. and Civica’s Executive Leadership Team.
• Carry out leadership and management responsibilities in accordance with Civica’s corporate policies and applicable laws for the industry.
• Effectively manage through clear, direct, and respectful communications, both within the site and through interactions at the corporate level.
• Establish site organizational performance goals and objectives.
• Interact with other functional disciplines throughout the company, as necessary, in achieving both site and company objectives.

Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in operations management in a pharmaceutical manufacturing environment, preferably in aseptic product manufacturing and/or injectable drugs.

• Exceptional leadership abilities to inspire and motivate others to perform well and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
• Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates’ skills and encourage growth.
• Experience in leading and managing cross-functional management teams within a matrixed reporting structure.
• Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
• Ability to identify and resolve complex problems in a timely manner, as well as skillfully gather and analyze information utilizing appropriate root cause analysis, FMEA, and other tools.
• Actively fosters a culture of continuous improvement by leveraging Operational Excellence methodologies and tools.
• Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
• Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and…