AVP, Quality Lead
Job Description
Position Overview - Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
Leads a multi-national team of ~450 professionals located in Americas, Europe, Africa and Asia Pacific region, responsible for Quality Operations at our Company’s Global Pharmaceutical Operations (GPO) packaging and device assembly sites. Provides leadership, direction and management of all quality assurance, quality control, micro / sterile, packaging and assembly, safety and regulatory compliance functions to effectively support all our manufacturing plants to supply commercial product and new product transfer activities as a safe, cost effective, high quality, business and cGMP compliant organization. Provides leadership and direction on all policies, guidelines and systems for the achievement of GMP compliance. Ensures that all products are manufactured, packaged, analyzed, released, stored and distributed in accordance with our Company and all applicable regulatory requirements to meet both internal and external customer demands. Drives for consistency, sharing of best practices and alignment of Quality and business processes associated with all internal and external partners. Single point of contact for packaging sites, responsible for establishing and maintaining all aspects of an organization of Quality professionals that ensures the quality performance through direct oversight and supervision, support and technical advice, talent development and succession planning. This includes ensuring appropriate Quality systems and guidance (e.g., our Company's Manufacturing Division's Quality Management System, QMS) are followed including permanent audit readiness, providing coaching and training; Quality Control; Quality Assurance such as product release and investigations; regulatory communication and compliance.
In addition, this position is a key member of the GPO Quality Leadership Team and participates fully within this structure to help define and lead strategy for the GPO Quality organizations and to monitor performance against expectations and objectives.
Primary Activities
Primary activities include, but are not limited to:
- Set direction, strategies, champion innovation, and continuous improvement within the organization to take the Quality function to successively higher performance. Works strategically and in collaboration with other functions to continuously improve effectiveness and efficiency in quality management. This includes managing all aspects of quality at ~6 internal manufacturing sites across the globe, and spanning pharmaceutical, biologics, vaccines, packaging, and devices.
- Responsible for the strategy, leadership, management and budgetary controls of a multi-cultural team of ~450 Quality professionals located globally (budget ~$60M). Works across different cultures and time zones.
- Accountable for permanent inspection readiness and regulatory compliance, including release or the coordination of release of product manufactured in accordance with worldwide regulatory requirements.
- Responsible for directing and managing major investigations, ensures that Fact Findings are organized appropriately and co-ordinates any recalls as appropriate.
- Provides direct support and technical expertise for the preparation for regulatory inspections and product launches and provides QA/ QC support such as product release, atypical investigations and charge control, etc.
- Reviews all inspection and audit outcomes and ensures appropriate and timely corrective actions.
- Establishes quality council oversight and quality plan per our Company's Manufacturing Division's Quality Management System (QMS). Establishes clear expectations, measures and periodic monitoring of operational and quality performance.
- Develops staff to ensure meaningful contributions, growth opportunities, and diverse succession candidates.
- Drives a culture of continuous improvement by deploying MPS tools within the Quality organization.
- Participates as a member of the senior Global Pharmaceutical Operations (GPO) Quality and Packaging and Device Assembly Business Unit Leadership Team and other committees as appropriate.
Skills
- BS (advanced degree preferred) in a relevant Science field.
- Minimum of 15 years’ experience in pharmaceutical industry.
- Experience with Quality Systems, Quality Assurance and Quality Control involving pharmaceutical manufacturing and packaging operations in compliance with global GMP and health regulatory requirements.
- Experience leading a Quality organization in a regulated industry, preferably the FDA / EMA / cGMP environment.
- Proven track record of managing complex Quality investigations, managing risk and being results driven and capable of rapid decision making.
- Strong health authority and compliance experience, being familiar with FDA, EMA, PMDA, CFDA, TGA.
- Significant Quality Operations experience in Quality Labs, Batch Release, and more.
- Demonstrable success leading global teams; able to sense and manage inclusive business cultures.
- Prefer experience with multiple manufacturing platforms (API, Solid Dosage, Packaging, Devices) in Quality, Operations or Technology roles, and in multiple plant sites.
- Complementary experience in, or exposure to, related functions such as Engineering, Supply Chain, Clinical and Commercial.
Travel:
- Ability to travel ~25% of the time, occasionally on short notice.
Current Employees apply HERE
Current Contingent Workers apply HERE
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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, 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.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”.
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
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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/22/2025*A job posting is effective until 11:59:59PM 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: R347959