Quality Control Manager

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Site Name: USA - Nebraska - Lincoln Posted Date: Dec 1 2021 $1,500 Sign-On Bonus Are you looking for an opportunity to manage, lead and implement long to midterm quality management plan to ensure the delivery of compliant products to customers? If so, this is the role for you. As Quality Control Manager, you will be responsible for the leadership and oversight of the Quality Control unit. You will establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Develops the strategy and clear operational plans for the department. Provides leadership to the QC department with responsibility for supporting and developing reports. Acts as a coach or mentor using appraisals, 1:1's, training and development, performance management, talent management and reward and recognition. Communicates effectively and establishes processes to ensure smooth communication within the department, across functions and across sites. Ensures two-way communications between Site Leadership and the department. Ensure proper planning and execution of testing of all samples and materials Ensure that analytical methods are adequately validated and maintained Ensure that analytical equipment is adequately calibrated and qualified prior to use and continuously kept in a qualified state Ensure that stability samples are testing on time and the stability program is adequately managed. Ensure that retention samples are adequately kept and assessed Ensures department's L1 audits are performed and supports/host L2, L3 and L4 audits. Actively participate in FDA and other regulatory inspections for the Lincoln Site; support the issuance of a timely response to the Agency for any observations. Approves GMP related documentation such as SOPs, CCRs, Deviations, Lab investigations, Stability reports, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in science, engineering or similar. Minimum of 8 years of experience in an FDA regulated industry Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11. Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level. Project management and leadership skills. Ability to work well under high pressure and deadlines Flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies. Excellent verbal and written communication. Conflict resolution and interaction management skills. Knowledge and application of the principles of Quality Management Systems (QMS). Computer Tools: Word, Excel, Power Point intermediate level. Why Consumer Healthcare? Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. Diversity, Equity and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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. 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