Merck · 1 day ago
Associate Director, Quality
Lansdale, PA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$129K/yr - $203K/yr
6+ years expMerck is a leading pharmaceutical company, and they are seeking an Associate Director for their Quality Environmental Monitoring team. The role involves ensuring compliance and quality of products and processes, overseeing environmental control, and managing various quality-related assignments within the organization.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Accountable for the oversight and sustained state of environmental control per the Environmental Monitoring Plan for Classified Areas; performing job functions located in classified operational, Controlled Non-Classified areas and within office settings
Works closely with assigned End to End (E2E) of Operations, Quality, Deviation Management, Technical Operations, and other cross functional groups in overall team environment, and respectively as independent contributor
Ensures all compliance requirements are met and can manage and meet required timelines for concurrent project workstreams across dynamic operational areas
Technical writing skillsets, ongoing independent management of variation of project workstreams, and ongoing authorship, review and/or quality approval of project workstreams to compile and analyze data for classified and controlled non-classified areas across E2E IPT’s are major components of job function
The attention to detail, executing and driving to completion work responsibilities Right First Time are expectations
Ensures compliance to federal and other regulatory agency requirements, cGMP (Current Good Manufacturing Practices), our companies Quality Systems and Quality Standard Operating Procedures (SOPs), Operational SOPs, and Systems Applications and Products (SAP) functions to assure a state of compliance is achieved in sustained and continuously improving manner
Accountable for actively adhering to, contributing, and meeting all Diversity, Equity, & Inclusion and Safety related requirements and expectations; adherence to mindset and efforts to take action are expectations across all ways of working
Must be capable of executing diverse workstreams utilizing notable leadership and independent decision-making skillsets, and can drive project closures efficiently, while upholding ongoing compliance for high-quality operations
Independently leads a variation of assignments related to regulatory commitments, deviation management, change management, quality risk and gap assessments, process simulations, media holds, continuous improvement, and other related workstream for EM Quality team
Will independently manage all phases of assigned projects and/or will lead and be accountable for leading other EM Quality Specialists in project development, management, and larger project tracking
Actively supports and will participate in on-site regulatory and related inspections / audits, contributes to ongoing inspection readiness state for classified areas and EM related documentation
Face-to-face inspector interactions are to be expected
Authors, and as applicable reviews and/or approves documentation for event-based multi-phased project streams
Additionally, manages routine, requalification, qualification of environmental classified area(s) related project protocols, reports, and data assessments
Ensures assigned areas of coverage are operating in a continued state of Environmental Control (EC) and is expected to utilize tier and other escalation processes in response to adverse events, trends, and other potentially impactful events in classified areas
Diligently responds to and provides subject matter expertise as it relates to potentially impactful EC events; these workstreams are associated with planned and unplanned activity that may warrant immediate response, at times during non-standard business hours
Such events require leadership skillsets to address situations with cross-functional representation, going into classified areas to evaluate, immediate project development, management, and other related activities to ensure immediate correction, prevention, and sustainment of environmental control is achieved
Effectively can identify where continuous improvements opportunities exist, both in response to events, as warranted per trends in metrics, and proactively, to ensure sustainment and improvement of environmental control and high-quality operations
Actively works to improve quality and related processes to ensure standardization, efficiency, and compliance across EM Team, E2E IPTs, E2E’s across site, as applicable. Is mindful and will be challenged to identify and develop innovative ways of working, proactively and for cause
Aides and/or oversee the review of daily Out of Specification Report and works with Deviation Management (DM) and other cross functional groups to evaluate/address associated events; this includes attending DM Tier(s) and other related meetings, active participation in deviation investigative processes, evaluation and development of corrective and preventative action, and routinely as needed, going to operational floor for assessment / completion of assigned tasks
Manages data and related information for E2E IPTs, as applicable to routine environmental performance assessments, against testing result specifications for classified areas
Can generate, comprehend, and analyze data and identify trends
Attention to detail and capability to author accurate detailed assessments of information is expected
Manages projects for process simulations, media holds, and special studies for assigned E2E IPTs, and concurrently participates in related workstreams
Manages the per process EM testing plans for applicable areas across E2E IPTS
Participates, leads, and/or manages assigned workstreams from EM Center of Excellence compliance and continuous improvement workstreams, applicable to the West Point EM Program and E2E IPTS
Learns, is knowledgeable, and capable of conducting Risk Based EM Assessments of on the floor EM sampling points and data/information comparisons, and other related tasks such as test site map updates and change control
Learns, is knowledgeable, and capable of representing EM quality role in the E2E IPTS Quality Risk and Gap Assessments, as applicable to compliance for conducting on a frequency basis and for-cause
Manages process and data related change requests for E2E IPTs
Manages workstreams for authoring new and revised SOPs and related documentation generated for or originating from E2E IPTS, as applicable to authorship, quality review, and/or quality approval
Leads and/or assists with phased training and on-going coaching of new and cross functional personnel, including but not limited to deviation management, EM investigations, EM program, GLIMS change control, process change control, and inspection support for E2E IPTS
Qualification
Required
Bachelor's degree in Microbiology, Biology, Chemistry, or other technical related scientific areas of study (technical operations, deviation management)
Minimum six (6) years of pharmaceutical quality, or related field of expertise (technical operations deviation management experience; this includes experience working within classified areas
Must be able to manage diverse quality related assignments (planned and unplanned) in independent, organized, and concurrent manner, while adhering to compliance requirements and strict timelines, across applicable E2E IPTs
Demonstrates versed skillsets in leadership and is comfortable and effective at communicating and independent decision-making, as applicable, across all levels of management, including upper management and cross-functional groups
Demonstrates immediate capability to lead assigned workstreams in independent and cross-functionally; can interact effectively with leadership
Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset; comprehension and use of these standards is to support the compliance and eventual sustainment of ongoing large-scaled projects, as warranted
Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance Indicators, meet significant project milestones, and lead an organization to meet priorities for the year
Technical writing skillsets, ongoing independent management of variation of project workstreams, and ongoing authorship, review and/or quality approval of project workstreams to compile and analyze data for classified and controlled non-classified areas across E2E IPT's are major components of job function
Attention to detail, executing and driving to completion work responsibilities Right First Time are expectations
Ensures compliance to federal and other regulatory agency requirements, cGMP (Current Good Manufacturing Practices), our companies Quality Systems and Quality Standard Operating Procedures (SOPs), Operational SOPs, and Systems Applications and Products (SAP) functions to assure a state of compliance is achieved in sustained and continuously improving manner
Must be capable of executing diverse workstreams utilizing notable leadership and independent decision-making skillsets, and can drive project closures efficiently, while upholding ongoing compliance for high-quality operations
Independently leads a variation of assignments related to regulatory commitments, deviation management, change management, quality risk and gap assessments, process simulations, media holds, continuous improvement, and other related workstream for EM Quality team
Will independently manage all phases of assigned projects and/or will lead and be accountable for leading other EM Quality Specialists in project development, management, and larger project tracking
Actively supports and will participate in on-site regulatory and related inspections / audits, contributes to ongoing inspection readiness state for classified areas and EM related documentation
Face-to-face inspector interactions are to be expected
Authors, and as applicable reviews and/or approves documentation for event-based multi-phased project streams
Additionally, manages routine, requalification, qualification of environmental classified area(s) related project protocols, reports, and data assessments
Ensures assigned areas of coverage are operating in a continued state of Environmental Control (EC) and is expected to utilize tier and other escalation processes in response to adverse events, trends, and other potentially impactful events in classified areas
Diligently responds to and provides subject matter expertise as it relates to potentially impactful EC events; these workstreams are associated with planned and unplanned activity that may warrant immediate response, at times during non-standard business hours
Such events require leadership skillsets to address situations with cross-functional representation, going into classified areas to evaluate, immediate project development, management, and other related activities to ensure immediate correction, prevention, and sustainment of environmental control is achieved
Effectively can identify where continuous improvements opportunities exist, both in response to events, as warranted per trends in metrics, and proactively, to ensure sustainment and improvement of environmental control and high-quality operations
Actively works to improve quality and related processes to ensure standardization, efficiency, and compliance across EM Team, E2E IPTs, E2E's across site, as applicable. Is mindful and will be challenged to identify and develop innovative ways of working, proactively and for cause
Aides and/or oversee the review of daily Out of Specification Report and works with Deviation Management (DM) and other cross functional groups to evaluate/address associated events; this includes attending DM Tier(s) and other related meetings, active participation in deviation investigative processes, evaluation and development of corrective and preventative action, and routinely as needed, going to operational floor for assessment / completion of assigned tasks
Manages data and related information for E2E IPTs, as applicable to routine environmental performance assessments, against testing result specifications for classified areas
Can generate, comprehend, and analyze data and identify trends
Attention to detail and capability to author accurate detailed assessments of information is expected
Manages projects for process simulations, media holds, and special studies for assigned E2E IPTs, and concurrently participates in related workstreams
Manages the per process EM testing plans for applicable areas across E2E IPTS
Participates, leads, and/or manages assigned workstreams from EM Center of Excellence compliance and continuous improvement workstreams, applicable to the West Point EM Program and E2E IPTS
Learns, is knowledgeable, and capable of conducting Risk Based EM Assessments of on the floor EM sampling points and data/information comparisons, and other related tasks such as test site map updates and change control
Learns, is knowledgeable, and capable of representing EM quality role in the E2E IPTS Quality Risk and Gap Assessments, as applicable to compliance for conducting on a frequency basis and for-cause
Manages process and data related change requests for E2E IPTs
Manages workstreams for authoring new and revised SOPs and related documentation generated for or originating from E2E IPTS, as applicable to authorship, quality review, and/or quality approval
Leads and/or assists with phased training and on-going coaching of new and cross functional personnel, including but not limited to deviation management, EM investigations, EM program, GLIMS change control, process change control, and inspection support for E2E IPTS
Preferred
Technical writing expertise
Experience working with Laboratory Information Management Systems
Experience in technical operations deviation management
Knowledgeable of Lean Leadership Principles
Experience managing direct reports
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
Company data provided by crunchbase