Piramal Group
Associate Director, Quality Assurance
Piramal Group, Sellersville, Pennsylvania, United States, 18960
Job Description
Business: Piramal Pharma SolutionsDepartment: QALocation: Sellersville, PATravel: N/A
Job Overview
The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations. Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software implementation meeting computer software regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5). This role will be critical point of contact with respect to clients to provide leadership and key updates for all Quality Operational activities.
Key Stakeholders: InternalTechnical OperationSupply ChainQuality Control, Quality Systems and ComplianceEngineering and FacilitiesAnalytical and Formulation Research and DevelopmentProject ManagementBusiness UnitKey Stakeholders: External
Clients - Commercial and ClinicalVarious Regulators including FDA, EU and PMDAReporting Structure
Reports to Director of Quality
KEY ROLES/RESPONSIBILTIES
Direct oversight of the following functions:
Personnel DevelopmentCommercial OperationsClinical OperationsData AuditingQA ITDirect oversight of Quality Assurance, ensures the activities are performed and closed in a timely manner, specifically:
Deviations (Events)CAPAChange ControlReview and approve controlled documents requiring QA approval signature, including:
Executed cGMP Batch RecordsMaster Batch Production RecordsStandard Operating ProceduresProduct, Process, Test Method, and Equipment Qualification Protocols
Participate in client project meetings as well as PPS project meetingDevelopment and issuance of operational metrics related to record executionServe as the Subject Matter Expert (SME) on Quality Operational support activitiesAccountable for the effective execution of processes carried out under departmental leaders (Pest Control, GMP Work Orders, Batch Disposition and Operational Quality Walk Through)Establish and track the relevant KPIsPeriodic "stand-in" stand-in for Head of Quality duties, as designatedCoordinates daily and monthly staffing schedules, capacity planning and cross-training effortsAssists QA management with identifying staffing needs and contributes to hiring decisionsProvide scheduling of data auditing to align with client objectivesProvide direction of CSV support needed for the site to ensure business continuity and support new equipment induction activities as well as an updates to software/hardware that are critical to the businessSupport/execute Supplier Management ProgramSupport/execute Annual Product ReviewManage Departmental BudgetSupport, serve as Subject Matter Expert for: internal, customer and regulatory audits/inspectionsExecute system/process gap analysis and implement CAPAs for identified gaps
Qualifications
Experience
Minimum of ten (10) years in Quality (QA, QC, QS and/or Compliance) with progressive experience in a regulated cGMP industry is required, with three (3) years' management experience. Must have experience working within a GMP oral solid dosage manufacturing environment. Contract development manufacturing experience is preferred.
Competencies
Strong written, verbal, and interpersonal communication skills, strong proficiency with GxP electronic systems such as SAP, Trackwise and Ensur (electronic document management system) and proficiency in MS Office. Role will also require a high attention to detail.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Pharma Solutions (PPS)
is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Business: Piramal Pharma SolutionsDepartment: QALocation: Sellersville, PATravel: N/A
Job Overview
The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations. Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software implementation meeting computer software regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5). This role will be critical point of contact with respect to clients to provide leadership and key updates for all Quality Operational activities.
Key Stakeholders: InternalTechnical OperationSupply ChainQuality Control, Quality Systems and ComplianceEngineering and FacilitiesAnalytical and Formulation Research and DevelopmentProject ManagementBusiness UnitKey Stakeholders: External
Clients - Commercial and ClinicalVarious Regulators including FDA, EU and PMDAReporting Structure
Reports to Director of Quality
KEY ROLES/RESPONSIBILTIES
Direct oversight of the following functions:
Personnel DevelopmentCommercial OperationsClinical OperationsData AuditingQA ITDirect oversight of Quality Assurance, ensures the activities are performed and closed in a timely manner, specifically:
Deviations (Events)CAPAChange ControlReview and approve controlled documents requiring QA approval signature, including:
Executed cGMP Batch RecordsMaster Batch Production RecordsStandard Operating ProceduresProduct, Process, Test Method, and Equipment Qualification Protocols
Participate in client project meetings as well as PPS project meetingDevelopment and issuance of operational metrics related to record executionServe as the Subject Matter Expert (SME) on Quality Operational support activitiesAccountable for the effective execution of processes carried out under departmental leaders (Pest Control, GMP Work Orders, Batch Disposition and Operational Quality Walk Through)Establish and track the relevant KPIsPeriodic "stand-in" stand-in for Head of Quality duties, as designatedCoordinates daily and monthly staffing schedules, capacity planning and cross-training effortsAssists QA management with identifying staffing needs and contributes to hiring decisionsProvide scheduling of data auditing to align with client objectivesProvide direction of CSV support needed for the site to ensure business continuity and support new equipment induction activities as well as an updates to software/hardware that are critical to the businessSupport/execute Supplier Management ProgramSupport/execute Annual Product ReviewManage Departmental BudgetSupport, serve as Subject Matter Expert for: internal, customer and regulatory audits/inspectionsExecute system/process gap analysis and implement CAPAs for identified gaps
Qualifications
Experience
Minimum of ten (10) years in Quality (QA, QC, QS and/or Compliance) with progressive experience in a regulated cGMP industry is required, with three (3) years' management experience. Must have experience working within a GMP oral solid dosage manufacturing environment. Contract development manufacturing experience is preferred.
Competencies
Strong written, verbal, and interpersonal communication skills, strong proficiency with GxP electronic systems such as SAP, Trackwise and Ensur (electronic document management system) and proficiency in MS Office. Role will also require a high attention to detail.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Pharma Solutions (PPS)
is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.