ASSOCIATE DIRECTOR, QUALITY ASSURANCE - THIRD PARTY QUALITY MANAGEMENT - HYBRID

Job Description The position will be heavily involved in close partnership with Active Pharmaceutical Ingredient (API) manufacturing contractors and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including Good Manufacturing Practice (GMP) qualification as well as site/project selection.
Additionally, the incumbent would serve as the bridge between research and development, and Commercialization activities and develop strong working relationships with external quality management personnel.
The incumbent would be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to discuss projects, operational/quality, and overall performance topics.
In addition to the job-specific tasks discussed above, the incumbent is expected to execute on the following.
Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations.
Provides project direction in the area of expertise in own discipline (such as directing or facilitating teams involving source area representatives in a matrix management environment).
Leads Quality-related reviews, cross-functional process teams, and/or investigations, serving as a subject matter expert.
Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities.
Makes decisions and acts with authority to carry out actions as applicable.
Coaches, mentors and develops colleagues in areas of expertise.
Guides others in a matrix environment.
Serves as a quality spokesperson on a variety of Quality or compliance-related issues.
Identifies trends and/or potential compliance gaps and proactively guides the resolution of long-standing or significant issues affecting quality and efficiency.
Interprets complex regulatory requirements for various audiences, reviews draft policies and standards.
Education Minimum Requirements.
Bachelor's degree in engineering, Chemistry or related field.
Required Experience and Skills.
Bachelor's Degree with 10+ years of relevant experience within the pharmaceutical industry or advanced Degree with 8+ years of experience.
Preferred Experience and Skills.
Small molecule manufacturing is not required but preferred.
Knowledge in Mandarin is not required but preferred Current Employees apply HERE Current Contingent Workers apply HERE 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 if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
For more information about personal rights under the U.
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Equal Opportunity Employment laws, visit.
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The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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Hybrid Work Model Effective September , employees in office-based positions in the U.
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will be working a Hybrid work consisting of three total days on-site per week, Monday - 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.
his 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”.
The salary range for this role is $ This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.
An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits.
Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.
erck.
om/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.
erck.
om/us/en (or via the Workday Jobs Hub if you are a current employee).
The application deadline for this position is stated on this posting.
San Francisco Residents Only.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance 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.
Regular Relocation.
No relocation VISA Sponsorship.
No Travel Requirements.
25% Flexible Work Arrangements.
Hybrid Shift.
1st - Day Valid Driving License.
Yes Hazardous Material(s).
No Required Skills.
Adaptability, Adaptability, Audit Management, Business, Chemical Biology, Compliance Investigations, Deviation Management, Global Program Development, Good Manufacturing Practices (GMP), Management Process, Organic Chemistry, Pharmaceutical Guidelines, Pharmaceutical Research, Policy Development, Product Commercialization, Project Leadership, Project Procurement Management, Project Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance {+ 4 more}  Preferred Skills.
Job Posting End Date.
*A job posting is effective until PM on the day BEFORE  the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID.
R