Quality Assurance Director jobs in Philadelphia, PA

Job Description

Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, vaccine manufacturing and/or microbiology laboratories for assigned topics.

Primary activities include, but are not limited to:

• Leads the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Manufacturing Division is compliant to cGMPs for these topics.
• Leads divisional projects across internal and external sites.
• Leads team in development of strategy and assigning project and site support for MQSA.

Education Minimum Requirement and Experience:

• Bachelor of Science (BS) Degree in Microbiology, Virology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with ten (10) years’ experience in sterile pharmaceutical industry. OR
• Master of Science (MS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with eight (8) years’ experience in sterile pharmaceutical industry. OR
• PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with six (6) years’ experience in sterile pharmaceutical industry

Required Experience and Skills:

• Broad experienced in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods.
• Expert knowledge of three or more microbiology/virology topics related to sterile, non-sterile, or biologic processing and/or microbiology/virology methods.
• Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA, EMEA, TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA and PMDA.
• Knowledge of USP and EU compendia and ISO industry standards.
• Quality Risk Management
• Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses.
• Excellent spoken and written English. Demonstrates strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position.
• Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R284084