Validation Manager II

Validation Manager II

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Location: Clayton NC

Summary: The Validation Manager II, is a senior Manager role within the department. This person is responsible for managing a validation program (current business/multiple business units) and large capital projects to support Grifols Therapeutics products. This role includes defining and prioritizing validation activities and resources to meet organizational objectives, ensuring that the validation program complies with all Grifols requirements and industry standards, and partnering with Manufacturing, Engineering, and Quality. This role is also responsible for setting expectations for the group/staff, and developing individual and team performance.

Primary Responsibilities:

• Manages all phases of validation by working with multiple departments: determines funding and resource requirements, evaluates projects for validation testing requirements, determines validation project timelines and priorities, manages validation budget, protocol development, approval, execution and reporting.
• Ensure that all calibration and validation efforts meet GXP and industry standards as appropriate. Proposes and administers plans to maintain systems in compliant calibrated and validated state.
• Oversee training, re-certification, requalification, and revalidation programs.
• Provides guidance and technical information to others and approves all business unit (BU) change control requests (CCRs).
• Supports project scope development activities with Engineering, verifies operating parameters during Operational Qualification (OQ), and coordinates with testing participants (Quality Assurance, Technical Operations) during all validation activities.
• Serves as the key liaison for global regulatory inspections and submissions for the company. Prepares annual product reviews for each product relative to validation changes/impact yearly.
• Reviews and approves all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
• Ensures all revalidation requirements are met for equipment, process and cleaning site wide.
• Ensures responsible group remains compliant with Safety, Performance Development, Quality Stewardship, SOP read and Review, and cGMP training requirements.
• Manages validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan. Directs supervision of contractors or other specialists.
• Reviews engineering drawings for compliance to GMP/Validation principles and provides feedback to engineering for any noted deficiencies or improvements.
• Leads initiatives to streamline processes and work flow by initiating Operational Excellence initiatives.
• Develops and implements new process characterization and revalidation program for all products manufacture at Clayton.
• Serves as the Committee member for approval of new product distributors, vendors and service providers.
• Interacts with management, senior management and stakeholders to determine project scopes, timelines and prioritization of global and local projects.
• Manage and develop staff by setting individual and group goals and manage performance based on Grifols guidelines.
• Provide leadership for the group and work with entry level Validation Specialist on developing and monitoring training at different intervals of their tenure.

Additional Responsibilities for Validation Manager II:

Interacts with senior executives (Managers, Director, VPs) internal and external to Grifols to develop project strategies and schedules. Reviews protocol acceptance criteria and manages project executions to minimize hold periods for millions of dollars of product. Provides effective leadership to employees in Validation, RA, QA and Engineering. Approves new product distributors, vendors and service providers. Supports other locations as needed.

Knowledge, Skills, & Abilities:

• Knowledge of plasma fractionation, protein purification, aseptic processing and filling, sterilization, GMP regulations and Quality operations. Excellent oral and written communication skills. Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action.
• Knowledge of FDA cGMP's, GXP's as required, Regulatory Compliance, Standard Operating Procedures, QA/QC documentation, and the ability to interpret engineering documentation required.
• Candidate shall be both motivated and committed to producing high quality work according to schedules and timelines.
• Strong leadership, organizational planning, project management skill, in addition to strong technical background required to coordinate multi-disciplinary teams.
• Excellent interpersonal effectiveness and communication skills (written and oral) required to work across departments and management levels.
• Successful Manufacturing, Quality Systems and Validation track record required.

Requirements:

• Requires a BS/BA degree in related field, such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics). An equivalent combination of education and experience may be considered based on business need.
• Minimum of 6 years proven technical/project management and leadership experience (combined) in the Validation industry, FDA, USDA environment. Experience in pharmaceutical processes (i.e. Bio-Pharmaceutical) required.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.