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Senior Manager or Associate Director, Quality Control

Waltham, MA
Closing date
Jul 27, 2021

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Other, Manufacturing/QA/QC
Job Type
Manager, President/CEO/Director/VP
Organization Type
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Site Name: USA - Massachusetts - Waltham Posted Date: Jul 7 2021 The Sr. Manager / Associate Director, Quality Control is responsible for leading the Quality Control function at GSK in support of CMC development activities and providing guidance to the Quality Control staff. The Sr. Manager / Associate Director will oversee operations pertaining to QC testing at contract testing laboratories and contract drug substance and drug product manufacturing sites. This responsibility includes vendor oversight, project management, data review, and exceptions management. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This position includes assisting with QC checks and preparation of regulatory filings (INDs and NDAs). This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Development and implement cGMP compliant procedures crucial to the successful operation of the Quality Control function. Provide both technical and operational chemistry expertise for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations. Provide leadership and direction to development project teams to ensure product quality guidelines are consistently met. Manages and develops the performance of direct reports by setting clear expectations, as well as resolving conflicts. Manage drug substance and drug product analytical testing at contract laboratories including investigation and resolution of analytical test failures (OOS and atypical results) Review QC raw data and assist in batch release. Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports Assemble data packages in support of specification and method changes associated with GSK products Represent QC in cross-functional teams with internal and external customers Contributes to appropriate sections of IND/IMPD and NDA/BLA/MAA filings, and approves various quality documents (internal and external) associated with GSK products Participate in vendor and internal audits as needed Contribute to company quality systems Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Requires minimum MS in Biochemistry, Chemistry or related field with 10+ years of supervisory experience in an analytical testing laboratory (including in a commercial environment) (Ph.D preferred). 8 years' experience considered for Sr. Manager Experience building relationships and working with CMOs Experience with analytical testing concepts and current cGMPs including laboratory controls and good documentation practices Experience managing and directing team of Quality Control managers (required for Associate Director, preferred for Sr. Manager) Experience with managing projects and working with cross-functional teams comprised of internal and/or external contacts Ability to travel (includes international), 10% Preferred Qualifications: If you have the following characteristics, it would be a plus: Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations Excellent written and oral communication skills. Competency in MS Office Products and Adobe Acrobat Independently motivated and detail oriented with good problem-solving ability. Ability to work a flexible work schedule to accommodate program priorities and international activities as needed Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *LI-GSK gskbiopharm_development 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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