职位描述

职位描述： Responsible for the successful management of a large multidisciplinary commercial Manufacturing Operations group for solid oral product Establishes departmental goals, objectives, staffing and operational budgets, creates and Aligns the strategy and objectives with the OpU and represents the department to senior management, outside companies or regulatory agencies. Ensures compliance with Standard Operating Procedures (SOPs), current good Manufacturing Practice regulations (cGMP), product licenses, corporate policies and safety practices. Operating Unit/perspective and to set priorities accordingly, based on overall strategies and goals. Oversees all Manufacturing/ projects and initiatives, is responsible for ensuring that state-of-the-art operational excellence tools such as Lean manufacturing and Six-Sigma are used to drive continuous improvement. Proactive planning and implementation to meet the current and future business needs of the corporation. High level of management expertise. The level of this position is based on scope of responsibility, managerial experience and competency, technical complexity, budgetary accountability, level of interpersonal/outside contacts, and critical thinking/decision making acumen. Responsibilities Organizational Leadership Responsible for the successful operation of the Dept. creates the strategy to meet the Business Goals. Directs the efforts of management staff responsible for the production of the product or completion of the process in compliance with all regulatory requirements, cGMPs and company policies, procedures and goals.Assures the appropriate interaction of support groups with Quality, Technology, Engineering & Maintenance, Supply Chain, Training, BT, Finance, Environmental Health & Safety and Human Resources/ Labor Relations.Meets with cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning. Works with support groups to develop priorities and strategies for completing cross- functional assignments to meet department goals and initiatives. Compliance & Quality Ensures the quality of the dept. - Develops and implements overall policies and strategies to ensure consistency and quality compliance of manufacturing procedures. Interprets, oversees and ensures the implementation of corporate global policies, site and business specific guidelines and relevant SOPs within department.Ensures that cGMP and safety training for all site staff within department is conducted in a timely, efficient and complete manner in order to meet regulatory compliance requirements. Partners with Quality head counterpart on related Quality and Compliance issues in the dept.Ensures operations are in compliance with corporate standards as well as federal and local regulationsOversees investigations and Operational Excellence initiatives, ensuring the use of tools like Lean Mfg and Six Sigma to improve quality, cost, safety and cycle time.Ensures the implementation of operational strategies and the coordination of activities within the broader strategic goals for the dept.Accountable for ensuring the overall compliance of the department with all boards of health and the internal compliance groups Process Improvement Develops and implements strategic direction for product or process improvements.Provides support for existing products. Leads site groups that support existing production and future product/process enhancement, through problem investigation, and the experimental evaluation of product and process quality to ensure the meeting of customer commitments.Executes product quality/production performance on time and within budget.Engages all department employees in the continuous improvement process right down to shop floor personnel. Cultivates a culture of continuous improvement. Customer focus Working with Op Unit leadership and Commercial, cultivates the strategic customer relationships and ensures that the customer perspective is the driving force behind all value-added business activities. Financial Develops operating budgets, labor and capital expenditures that are consistent with short and long-term site master plans and approved budget.Drives cost decreasing projects Facilities Plans and implements site strategies for both the short-term maintenance and long-term acquisition of equipment.Participates in facility planning to ensure that both short-term and long-term product/process business objectives are met.Supports the implementation of network wide systems within dept. Talent Management Coaches and counsels employees on a timely basis regarding performance (behavior, skills and attitude) to form a high performance team.Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of leadership staff and other critical roles. Identifies development opportunities for staff and prepares staff for future promotional growth.Actively participates in succession planning to ensure dept. maintains flexibility and the ability to quickly respond to changes in personnel. Work Flow In partnership with Sr. Management, this position develops strategies to ensure efficient work methods are in place for production to meet corporate and regulatory requirements. Generally accomplishes results by working with Sr. Management and/or corporate Supply Chain Management to implement strategies, programs and processes that are aligned with company goals. Output is delivered to the supply chain network and senior management. Decision Marking Talent Management - Responsible for overall performance and salary recommendations for the group. Makes budgetary decisions. Final Authority; review concurrence of site leader Policies and Procedures - Establishes operating policies, procedures, and directives for the dept. - Final Authority Financial - Develops and approves capital plan necessary to support business needs. Authorizes purchase orders for equipment, services and supplies - Final Authority. Develops Annual Business Plan for the dept. - Shared Decision with site leader/Finance Disposition Decisions - collaborates with Quality Management - Participates Decisions impact production process effectiveness, cost, quality and delivery of final product/ process. Decisions impact overall organizational effectiveness at the site in both the short and long term. Decisions may impact customer service and financial health of the company. Incumbent will use judgment as to when to consult with the site leader. Will generally consult with Managing Director or other Dept heads if significant staff, quality, cost or compliance issues exist. Decisions also guided based on applicable regulatory/government requirements, corporate policies and procedures and safety/environmental regulations. Supervision The incumbent receives consultative and strategic direction from site Sr. Management/site leader. The position is mainly independent and the incumbent is primarily responsible for execution according to site/operating unit strategy.The work is checked based on key performance indicators agreed upon with the site leader/Operating Unit.Typically has back up/signatory authority for the site leader in his/her absence.Budget/Asset Responsibility Budget preparation for department programs and processes including headcount and capital expenses. Minimize unnecessary costs and inefficiencies. Ingenuity Creativity and innovation are required when incumbent independently designs, executes and reports results of work.Solves the majority of issues that arises, and provides possible solutions to Sr. Management when decisions must be made at higher level.Executes on projects with high levels of risk. Completion of projects involves creativity and innovation in application of existing methodologies.Devises strategies to achieve goals. Cascading information and cultivating a continuous improvement culture throughout the entire organization requires the incumbent to creatively enroll a large workforce. Planning Designs, develops and evaluates plans for department. Completely responsible for planning and execution of all tasks needed to achieve both routine and stretch goals. Working with functional department heads, develops long-range plans for the department.Works with Supply Chain to develop a strategic plan including capital needs, labor resource needs, and facility improvement needs to meet long range production forecasts. Technical/Other Competencies Selling the Vision Passionately sells an organizational strategy; uses the vision as a reference point in conducting own day-to-day activities; translates the vision for employees by describing how what they do on a day-to-day basis impacts customers. Lead with vision and a sense of optimism; plan ahead to meet future needs.Change Leadership Continuously seeks (or encourages others to seek) opportunities for different and innovative approaches to addressing organizational problems and opportunities.Takes ownership for achieving company priorities, think broadly to develop strong business solutions and act to achieve customer expectations and envisioned outcomes.Communication with Impact Expresses thoughts, feelings, and ideas in a clear, succinct, and compelling manner in both individual and group situations; adjusts language to capture the attention of the audience.Talent Management Uses appropriate methods and interpersonal styles to develop, motivate, and guide a team toward successful outcomes and attainment of business objectives. Promotes an inclusive work environment and attracts and retains diverse talent. Be accountable for building talent at all levels of organization, including self, creating a diverse pipeline of leaders.Building a Successful Team Develops direction: ensures that the purpose and importance of the team are clarified, guides the setting of specific and measurable team goals and objectives.Involve others: listens to and fully involves others in team decisions and actions, values and uses individual differences and talents. Reach within and across functional boundaries, encourage diverse ideas and work effectively with different styles to enhance teamwork.Developing Strategic Relationships Uses appropriate interpersonal styles and communication methods to influence and build effective relationships with business partners (e.g., peers, functional partners, external vendors, and alliance partners) to help achieve business goals. Understand the global forces affecting the industry and anticipate the implications for the business, for stakeholders and for the work we do.Driving for Results Conveys an image that is consistent with the organization's values; demonstrates the qualities, traits and demeanor that command leadership respect. Sets realistic but stretch goals . Advocates the organization. Focus on the detailed implementation of goals, strategies and work assignments Champion innovation, challenge conventional thinking and implement operational improvementsCustomer Orientation Cultivating strategic customer relationships and ensuring that the customer perspective is the driving force behind all value-added business activities.Operational Decision Making Relates and compares; secures relevant information and identifies key issues; commits to an action after developing alternative courses of action that take into consideration resources, constraints, and organizational values. Make high quality and timely decisions by applying sound judgment Solicit advice, encourage debates and make the tough decisions about the business and people. Qualifications Bachelor's or Masters' degree in a technical discipline is required. Advanced degree preferred.Training in cGMP's, Quality, relevant SOP's/Policies, Operational Excellence tools and processes used at siteRelevant pharmaceutical or related area experience essential, including a number of years at managerial level within a large manufacturing organization Manufacturing, research and industry experience in site processes/products, experience in dealing with Regulatory compliance.Experience and skill in Business Management and Finance. Experience in problem solving, negotiations, presentation and supervision of a multi-layered organization. Multi-discipline experiences including but not limited to the following: Materials ManagementQA/QCTechnologyEngineering/Maintenance 职能类别： 生物工程/生物制药

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