Job Description

Purpose of the Position

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.

Key Responsibilities

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.

Experience and Professional Qualifications

• 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 maintain compliance with legal and regulatory requirements.
• Promote and observe safety and security procedures for all equipment, materials, and activities at the site.
• Ability to multi-task and drive change in a fast-paced operations environment.
• Thorough understanding and experience in developing and implementing business strategies through knowledge of company history, culture, identity, and goals.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyses information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Pursues training and development opportunities; Strives to continuously improve and build knowledge and skills.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments; Maintains confidentiality.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
• Written Communication - Writes clearly and informatively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.
• Adaptability - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Monitors transition and evaluates results; Able to deal with frequent change, delays, or unexpected events.
• Delegation - Delegates work assignments; Gives authority to work independently; Sets expectations and monitors delegated activities.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff and others; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Improves processes, products and services.; Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals; Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Diversity - Demonstrates knowledge of EEOC policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Supports affirmative action and respects diversity; Builds a diverse workforce.
• Ethics - Treats people with respect; Works with integrity and ethically; Upholds organizational values.
• Strategic Thinking - Understands organization's strengths and weaknesses; Analyzes market and competition; Adapts strategy to changing conditions.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; Looks for ways to improve and promote quality; Monitors own work to ensure quality.
• Safety and Security - Observes safety, environmental and security procedures. Reports potentially unsafe conditions.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and other computer software, as required.

Education

BS in biology, chemistry, chemical engineering or related field. Six Sigma background would be a plus.