Director, Quality Assurance Systems

Job Description
The Director, Quality Assurance Systems uses available information channels to maintain compliance proficiency and utilizes this information to identify and evaluate emerging trends for incorporation to Quality Systems requirements.
These information channels include:

• Participation in regulatory inspections
• Review of inspection reports from other sites/agencies and regulatory agency publications
• Attending and participating in local quality forums, industry working groups, or internal teams as needed
• Acts as the primary liaison to support Quality System enhancements as required by a variety of signals (e.g. inspection outcome, regulatory surveillance, performance improvement need)
• Responsible for hiring and ensuring Quality Assurance personnel are trained, and administers all personnel policies and development programs
• Ensures personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable governing regulations
• Utilizes personal capacity in an efficient manner to ensure on-time output of customer needs

Primary Responsibilities

• Directly leads activities in the execution of quality system functions relating to pharmaceutical and vaccine GMP compliance; additionally, is frequently called upon to champion multi-department, site-based teams regarding various compliance initiatives and assessments
• Coordinates and directs teams of multi-disciplined professionals in areas of process and systems, as they relate to quality system enhancements. Oversees the execution, robustness and performance improvement of a subset of key Quality Systems, that could include: Change Control and Automation Change Control | Documentation, including SOPs and batch records | Records retention | Quality Oversight of outsourced tasks | Annual Product Reviews

Note: Agency reporting of BPDRs and FARs, and market actions; Internal auditing; CAPA and Commitment management are key systems that may require support but are not within the direct oversight of the role.
Education Minimum Requirement and Experience

• Bachelor's Science degree (BS) in scientific, engineering, or related field of study with ten (10) years' work experience in a medical device, pharmaceutical, biologic and/or vaccine manufacturing environment or a strongly related, similarly regulated field

Required Experience and Skills

• Concurrently, four (4) years of managerial experience, with responsibility for direct and indirect reports
• Extensive understanding of cGMPs, FDA and EMEA regulatory standards with a solid compliance mindset
• Excellent writing skills
• Effective Lean mindset with MPS/Kata capabilities
• Ability to be self-motivated and work independently, yet collaboratively in team settings and within matrix organizations to achieve objectives
• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position

Preferred Experience and Skills

• Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA/MS/MA degree in addition to the required science or engineering education, is a plus
• Sterile/Vaccines manufacturing companies or regulatory authorities
• Compliance remediation activities at plant sites
• Plant audits and Supplier Audits
• Regulatory Commitments implementation and effectiveness
• Minimum of two (2) different management pathway roles or experiences
• Accountable for actions, drives results, and learns from mistakes
• Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
• Communicates influences and escalates issues and decisions, as appropriate
• Goes to the shop floor to see the problems and work directly with people on the shop floor
• Demonstrates tolerance for ambiguity
• CAPAs effectiveness and Implementation
• Documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls

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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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".
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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:
On-Site
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a