- The Sr. Manager understands industry-wide and regulatory expectations for Facility, Utility, Equipment, and Cleaning Validation, and works with other members of management to ensure validation practices are consistent with requirements and expectations.
- Utilizes industry experience to drive the assessment and improvement of site validation practices;
- functions as the representative on global Validation initiatives; ensures that site validation practices meet corporate requirements;
- collaborates with site Quality Assurance to determine an agreed-upon path forward on matters of Validation philosophy, implementing those philosophies, and incorporates into the standard operations of the department;
- defends validation protocols and explains concepts and policies to Regulatory inspectors;
- develops and manages studies to respond to Regulatory observations; manages the development of Validation Project Plans, Annual Validation Assessments, and similar summary documents;
- manages the development execution, tracking, and review of validation testing protocols for completeness, cGMP and data acceptability;
- manages the development and performance of direct reports, including yearly goals, mid-year and end-of-year performance reviews, compensation increases, and promotions, as applicable.
- Management of validation staff that provides oversight to, and executes, the validation program.
- Provides mentoring and coaching of the staff and is focused on personnel development
- Manages all aspects of the Validation Department in accordance with current guidelines on equipment, automation, utilities, facilities, and cleaning validation, in compliance with pertinent regulations (e.g., FDA, EMA).
- Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules.
- Ensures global procedure alignment with QMS
- Assesses overall validation workload, staffs accordingly, and deploys resources to attain Engineering and production goals.
- Manages and tracks the execution of all relevant validation activities within the Manufacturing areas, integrating their timeline with ongoing projects and programs
- Coordinates participation on Tech Transfer and capital projects. Commissioning
- Presents and defends validation systems to Regulatory Inspectors and outsourced partners.
- Provides validation information for regulatory filings and regulatory agency requests
- 10+ years total experience in the areas of GMP validation, manufacturing, engineering or facilities in a pharmaceutical environment.
- Collaborative attitude with the willingness to work with global peers toward company and department goals.
- Focused dedication with the willingness to do what it takes to get the job done.
- Excellent communication and presentation skills (oral and written).
- Experience negotiating with and managing contractors, vendors, and/or outsourced services.
- Ability to organize personal tasks and concurrently monitor direct reports tasks / assignments.
- Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulations.
- Experience dealing with FDA investigators, authoring responses to critical, major or minor observations and implementing corrective measures.
- Experience in coordinating / leading cross-site or cross-functional initiatives
Bachelor’s Degree with a minimum of 10 years related industry experience or an MBA/MS with a minimum of 10 years related industry experience
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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