Mallinckrodt Pharmaceuticals
Job Title
Mgr Quality
Requisition
JR000015209 Mgr Quality (Open)
Location
Webster Groves, MO
Additional Locations
Job Description Summary
Job Description
SUMMARY OF POSITION:
The position provides Quality oversight and support for Webster Groves manufacturing facility. The position will provide leadership and support for continued operation of the facility. The oversight includes signature authority, with responsibility for escalating high risk issues to management. The position is responsible for decisions relating to quality and project actions. The position is responsible for project decisions, risk identification, risk mitigation and cross-functional support with entire team (operations, regulatory affairs, science and technology, etc…). The main result of the incumbent is to ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products as well as projects such as tech transfer, new product introductions and inspection readiness.
ESSENTIAL FUNCTIONS:
Provide leadership and support for the cGMP facility
Provide QA oversight, including but not limited to:
Change management
Investigations (process, complaint, and laboratory)
Product release
In process controls
Annual Product Review
Master documents (batch records, methods, labels, etc…)
Facility/Equipment Qualification and validation (process/cleaning)
Stability data review / stability coordination
CAPA
Develop and execute validation and compliance strategy for Webster Groves commercial plant
Conducts/Coordinates supplier audits and supports audits as part of the audit team, as needed
Identify, develop and execute project plan and timelines to achieve desired results
Liaise with other intracompany facilities (Hobart, STLP) for laboratory testing and other needed support
Participate actively in cross-functional teams supporting the Webster Groves commercial plant and projects
Serve as leading technical expert for key quality or compliance areas
Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with facility management and oversight
Ensure facility is prepared for FDA and other regulatory body inspections
Support scorecard development, maintenance, reporting and action / project development from scorecards
Evaluate and provide risk-based QA decisions on all systems and issues that are/may be affected by regulatory or cGMP requirements – escalate to senior leadership as appropriate
MINIMUM REQUIREMENTS:
Education:
Minimum BS in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies
Advanced degree preferred
Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
Certification as a Quality Auditor or Quality Manager helpful
Experience:
Minimum 5 years’ experience in a quality engineer or equivalent role
Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
Preferred experience including, but not limited to the following:
Solid dose product experience
Application of cGMP to manufacturing and testing
Product release and investigations
Change Management and CAPA
FDA inspections / Regulatory Affairs
Validation
Skills/Competencies:
Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
Critical problem-solving skills
Demonstrated data driven decision making ability
Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)
An understanding of the pharmaceutical industry and its unique business and social responsibilities
Excellent facilitation and presentation skills
Ability to plan, organize, and prioritize
Excellent technical and compliance-based writing skills
Ability to work with clients of diverse incumbent skill base
Ability to manage projects involving multiple functional groups without direct reporting authority
Other Skills/Competencies:
Strong communication skills
Demonstrated leadership abilities
Demonstrated commitment to excellent customer service
Conflict resolution skills
Requires mature judgment in problem solving situations.
Requires negotiation skills to effectively influence others
Ability to identify and drive continuous quality improvement
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Reports to Head of Quality
Dotted line relationship with Operational Manager
Works under self-direction toward predetermined long-range goals and objectives
Assignments and tasks are self-initiated and self-monitored
Determines and pursues courses of action necessary to obtain desired results
Requires minimal direction
Routine interaction with other company manufacturing facilities and corporate functions
WORKING CONDITIONS:
Office, production and laboratory environment
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)
Mgr Quality
Requisition
JR000015209 Mgr Quality (Open)
Location
Webster Groves, MO
Additional Locations
Job Description Summary
Job Description
SUMMARY OF POSITION:
The position provides Quality oversight and support for Webster Groves manufacturing facility. The position will provide leadership and support for continued operation of the facility. The oversight includes signature authority, with responsibility for escalating high risk issues to management. The position is responsible for decisions relating to quality and project actions. The position is responsible for project decisions, risk identification, risk mitigation and cross-functional support with entire team (operations, regulatory affairs, science and technology, etc…). The main result of the incumbent is to ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products as well as projects such as tech transfer, new product introductions and inspection readiness.
ESSENTIAL FUNCTIONS:
Provide leadership and support for the cGMP facility
Provide QA oversight, including but not limited to:
Change management
Investigations (process, complaint, and laboratory)
Product release
In process controls
Annual Product Review
Master documents (batch records, methods, labels, etc…)
Facility/Equipment Qualification and validation (process/cleaning)
Stability data review / stability coordination
CAPA
Develop and execute validation and compliance strategy for Webster Groves commercial plant
Conducts/Coordinates supplier audits and supports audits as part of the audit team, as needed
Identify, develop and execute project plan and timelines to achieve desired results
Liaise with other intracompany facilities (Hobart, STLP) for laboratory testing and other needed support
Participate actively in cross-functional teams supporting the Webster Groves commercial plant and projects
Serve as leading technical expert for key quality or compliance areas
Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with facility management and oversight
Ensure facility is prepared for FDA and other regulatory body inspections
Support scorecard development, maintenance, reporting and action / project development from scorecards
Evaluate and provide risk-based QA decisions on all systems and issues that are/may be affected by regulatory or cGMP requirements – escalate to senior leadership as appropriate
MINIMUM REQUIREMENTS:
Education:
Minimum BS in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies
Advanced degree preferred
Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
Certification as a Quality Auditor or Quality Manager helpful
Experience:
Minimum 5 years’ experience in a quality engineer or equivalent role
Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
Preferred experience including, but not limited to the following:
Solid dose product experience
Application of cGMP to manufacturing and testing
Product release and investigations
Change Management and CAPA
FDA inspections / Regulatory Affairs
Validation
Skills/Competencies:
Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
Critical problem-solving skills
Demonstrated data driven decision making ability
Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)
An understanding of the pharmaceutical industry and its unique business and social responsibilities
Excellent facilitation and presentation skills
Ability to plan, organize, and prioritize
Excellent technical and compliance-based writing skills
Ability to work with clients of diverse incumbent skill base
Ability to manage projects involving multiple functional groups without direct reporting authority
Other Skills/Competencies:
Strong communication skills
Demonstrated leadership abilities
Demonstrated commitment to excellent customer service
Conflict resolution skills
Requires mature judgment in problem solving situations.
Requires negotiation skills to effectively influence others
Ability to identify and drive continuous quality improvement
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Reports to Head of Quality
Dotted line relationship with Operational Manager
Works under self-direction toward predetermined long-range goals and objectives
Assignments and tasks are self-initiated and self-monitored
Determines and pursues courses of action necessary to obtain desired results
Requires minimal direction
Routine interaction with other company manufacturing facilities and corporate functions
WORKING CONDITIONS:
Office, production and laboratory environment
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)