Associate Director, Quality Systems & Compliance

Job Description

Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.Position Responsibilities:

The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.

Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.

Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.

Maintain an understanding our company policies, procedures, and guidelines.

Maintain awareness of evolving industry and regulatory trends/regulations.

Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits

Coordinate with Site Quality leads on audit refusals and postponements.

Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations

Education Minimum Requirement and Experience:

Bachelor’s degree in science (BS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with ten (10) years’ experience performing audits and/or quality operations experience. OR

Master’s degree in science (MS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with eight (8) years' experience performing audits and/or quality operations experience.

Required Experience and Skills:

Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas: Medical Device/Combination products, Biologics, Vaccines, API’s, Non-sterile Drug Products, or Sterile Drug Product manufacturing. Biologics auditing experience is required.

Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.

Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

Ability to work independently with limited supervision in a virtual-management environment.

Excellent communication, negotiation, influencing, and strategic thinking skills.

Review and approve audit reports (as assigned).

Must be detail oriented and organized.

Must be a positive change agent and able to adapt in a dynamic environment.

Must have the ability to travel globally approximately 50% of the time.

Preferred Experience and Skills:

Extensive experience auditing biologics and vaccine manufacturing sites.

External engagement in regulatory or industry forums.

Prior experience at a health authority performing GMP inspections.

Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.

Demonstrated ability to lead and drive results for business initiatives.

Demonstrated ability for process improvement.

Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/processes, or technical areas.

Experience with development, implementation ,and optimization of IT tools to deliver business outcomes.

Travel Expectation:

Minimum 50% travel

NOTICE FOR INTERNAL APPLICANTSIn 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.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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”.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:50%Flexible Work Arrangements:RemoteShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequisition ID: R292313