Validation Manager

Profile

Site Name:
USA - Maryland - Rockville
Posted Date:
Feb 23 2022
GSK is currently looking for a Validation Manager to join our team in Rockville, MD. The primary responsibility is to provide leadership and technical support for the validation group by interacting with customers (area supervisors/managers/end users) to establish project timelines and expectations, ensuring that operational execution is in compliance to validated parameters.
KEY RESPONSIBILITIES:
Provide leadership and technical support for the validation group
Establish project timelines and expectations, ensuring compliance to validated parameters
Providing technical consultation to area supervisors as it relates to quality, safety, and environmental requirements, and appropriately investing in new technologies to ensure continued compliance.
Work with Validation Associate Director to define, recommend, and justify validation budgets, capacity, personnel, and capital equipment needs.
Interface with management personnel in Engineering, Manufacturing, Quality Assurance, Regulatory Affairs, etc.
Participating in development and implementation of Validation policies and procedures.
Provide leadership and technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems.
Prepare and present technical investigative reports.
Evaluate, select and coordinate contract assistance in generating validation protocols and reports.
Lead cGMP training programs related to facility and equipment.
Support Validation Associate Director and Engineering Director by interacting with regulatory authorities during Site inspections relative to facility and equipment cGMP areas; supports successful management of inspections.
Ensures Self Inspection procedures for area of responsibility are in place and in use. Participate in a sampling of Self Inspections for the area(s) of responsibility.
Perform other functions as necessary or as assigned.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS in a Scientific, Engineering, Computer Science or equivalent related discipline
Minimum of 5 years of industry-related experience (Validation, QA, QC, manufacturing) and minimum of 2 year of hands-on validation experience.
Minimum of 4 years of practical work experience in the pharmaceutical or other FDA regulated field involving participation in validation test execution.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Working knowledge of validation test instruments and equipment.
Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
Proven knowledge on validation of a large number of GxP systems and sterilization processes. Ideally, must be recognized as an expert in at least one validation area (cleaning, analytical equipment, sterilization, process equipment, utilities, or biopharmaceutical manufacturing).
Extensive knowledge of 21 CFR 11 requirements.
Understanding of aseptic processing applications and biopharmaceutical manufacturing building design.
MicrosoftO Word, Excel and Project experience required.
Extensive knowledge of cGMPs.
Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
*LI-GSK
If you require an accommodation or other assistance to apply for a job at GSK, please **** (US **** (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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