Associate Director, Laboratory Quality and Support
Job Description
Our Quality Operation 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Under general direction of the Director, Quality Control, the Associate Director is accountable for directing a team of managers and individual contributors who are accountable to provide support functions to the laboratory operations. The support includes, but not limited to, quality assurance operation/compliance for the laboratory, equipment qualification/calibration, test method qualification, test method transfers, change control, laboratory deviations. The individual will also manage the Stability Program.
The QC Associate Director will drive continuous improvement and supports sustainability of implemented changes identified through lean tools or from other efforts. Accountable to implement productivity enhancements to streamline activities to meet or exceed customer expectations.
Responsibilities
Leading the activities that includes laboratory quality assurance operation, compliance, data integrity, equipment qualification/PM program, change control, QRA, laboratory deviation management, and stability program.
Manages a staff that edits, writes, and/or approves departmental procedures.
Ensure cGMP and GDP compliance.
Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas.
Performing duties and responsibilities of the Director in his/her absence
Administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration
Participates in the generation and interpretation of divisional policies/guidelines
Supports initiatives that involve the necessary human and capital resources needed to meet present and future quality control needs and managing those resources to meet annual profit plan
Supports the achievement of plant objectives (e.g., metrics, productivity, etc.)
Aligning resources with business unit needs
Minimum Education Requirement and
Experience:
Bachelor's Degree (BA/BS) in a science-related discipline (preferably in Chemistry, Biology, or Microbiology) with eight (8) years of experience in a cGMP pharmaceutical laboratory
Required Experience and Skills:
Five (5) years of direct people management experience
Experience in Quality Control Laboratory, Analytical and Microbiological Testing
Provide technical direction and training to include Good Manufacturing Practice, safety practices, and good documentation practices as they relate to the quality assurance of the product
General leadership skills to manage large teams, champion of diversity and inclusion
Prior expert level experience in LC (HPLC, UHPLC), GC, empower, method validation/transfer, titration, dissolution, content uniformity, data integrity requirements, OOS/OOT investigations and stability programs
Preferred Experience and Skills:
Working knowledge of SAP and Company Production System (CPS) principles
Working knowledgeable in the use of GLIMS and Empower
Excellent technical writing skills, presentation skills, root cause analysis, technical troubleshooting
Audit scenarios-internal and regulatory audits
Managing stability programs
Excellent Interpersonal and Communication Skills
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.
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.
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
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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
U.S. Hybrid Work Model
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.
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/aEstimated Salary: $20 to $28 per hour based on qualifications.
Our Quality Operation 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Under general direction of the Director, Quality Control, the Associate Director is accountable for directing a team of managers and individual contributors who are accountable to provide support functions to the laboratory operations. The support includes, but not limited to, quality assurance operation/compliance for the laboratory, equipment qualification/calibration, test method qualification, test method transfers, change control, laboratory deviations. The individual will also manage the Stability Program.
The QC Associate Director will drive continuous improvement and supports sustainability of implemented changes identified through lean tools or from other efforts. Accountable to implement productivity enhancements to streamline activities to meet or exceed customer expectations.
Responsibilities
Leading the activities that includes laboratory quality assurance operation, compliance, data integrity, equipment qualification/PM program, change control, QRA, laboratory deviation management, and stability program.
Manages a staff that edits, writes, and/or approves departmental procedures.
Ensure cGMP and GDP compliance.
Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas.
Performing duties and responsibilities of the Director in his/her absence
Administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration
Participates in the generation and interpretation of divisional policies/guidelines
Supports initiatives that involve the necessary human and capital resources needed to meet present and future quality control needs and managing those resources to meet annual profit plan
Supports the achievement of plant objectives (e.g., metrics, productivity, etc.)
Aligning resources with business unit needs
Minimum Education Requirement and
Experience:
Bachelor's Degree (BA/BS) in a science-related discipline (preferably in Chemistry, Biology, or Microbiology) with eight (8) years of experience in a cGMP pharmaceutical laboratory
Required Experience and Skills:
Five (5) years of direct people management experience
Experience in Quality Control Laboratory, Analytical and Microbiological Testing
Provide technical direction and training to include Good Manufacturing Practice, safety practices, and good documentation practices as they relate to the quality assurance of the product
General leadership skills to manage large teams, champion of diversity and inclusion
Prior expert level experience in LC (HPLC, UHPLC), GC, empower, method validation/transfer, titration, dissolution, content uniformity, data integrity requirements, OOS/OOT investigations and stability programs
Preferred Experience and Skills:
Working knowledge of SAP and Company Production System (CPS) principles
Working knowledgeable in the use of GLIMS and Empower
Excellent technical writing skills, presentation skills, root cause analysis, technical troubleshooting
Audit scenarios-internal and regulatory audits
Managing stability programs
Excellent Interpersonal and Communication Skills
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.
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.
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
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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
U.S. Hybrid Work Model
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.
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/aEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
