MANAGER TECHNICAL QUALITY OPERATIONS(Corporate Office)
NATURE AND SCOPE:
Review and approval of technical documentation, including but not
limited to; Deviations, Complaint Investigations, and CAPA; APR Summary Reports; Internal
and External Audit Reports; Technology Transfer protocols and reports; Stability protocols
and reports; and Validation and Qualification Protocols and Reports.
Manage and assign TQO staff in assessing and facilitating the resolution
of deviation and complaint investigations as necessary. This includes the identification and follow-up of CAPA.
Manage and assign TQO staff in review and approval of tech transfer documentation, R&D protocols and reports, validation and qualification protocols and reports, and change control justifications.
Manage and assign TQO staff in the scheduling, performance, and reporting of internal and external (i.e. Contract Manufacturers, APIs, Excipients, Container Closure, Testing
Laboratories, and others as necessary) quality audits. Reviews and approves audit reports and recommend corrective actions, if necessary, and the verification of corrective actions.
Manage the Annual Product Review process
Manage TQO staff for the initiation and implementation of technical projects, as necessary.
Act as a Liaison between QA and other departments on technical issues and report back to the Director of QA.
Identify quality process improvements to increase efficiencies and performance of
systems, operations and personnel.
Identify and resolve objectionable cGMP issues which may impact quality and reports to
Ensure all work is performed and documented in accordance with existing Company
policies and procedures, as well as cGMP and health and safety requirements in the
markets where product is sold.
Bachelors’ degree in Science related field.
5+ years in a pharmaceutical setting with at 3 years management experience.
Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP)
requirements and guidelines and documentation practices.
Strong technical writing skills.
Ability to lead cross functional teams.
SENIOR MANAGER ENGINEERING (Corporate Office)
NATURE AND SCOPE:
This position directly manages engineering and maintenance of three facilities, all utilities, and manufacturing equipment in an FDA regulated environment. Excellent managerial, communication, and technical skills are necessary to support current and future operations.
Plan, direct and coordinate all engineering functions for facilities, utilities and manufacturing operations activities.
Prepare all capital budgets, manage annual capital budgets and prepare capital expense forecast updates.
Conduct facility space planning, allocation, and development of additional space as required, perform cost analysis, and research facility alternatives.
Review projects, develop RFP’s, conduct bidding, review quotes and oversee installations.
Establish work plans and staffing for each phase of project and review status on an ongoing basis.
Oversee security for Luitpold and all security systems for all buildings.
Oversee housekeeping of all buildings.
Ensure 24 hour support and emergency response for all critical building systems, ensure reliability of all equipment and utility support systems, ensure adequate training of all mechanics, co-ordinate with all utilities/Local Fire Department/Police during any emergency.
Bachelor’s of Science in Engineering required, MBA preferred
Minimum of 5 years project engineering experience
Possess a strong working knowledge of mechanical, electrical, HVAC, water, fire suppression and structural systems.
Have a strong working knowledge of the construction process.
Exercise excellent managerial skills with a proven track record.
Use strong oral and written communication skills in the preparation and delivery of presentations.
Proficient in AutoCAD, MS Office and Outlook.
Possess knowledge of telecommunications and modern security systems.
PROJECT MANAGER (Corporate Office)
Responsible for all aspects of project management for Quality Assurance, Quality Control and Manufacturing.
Possess a clear understanding of the QA, QC and manufacturing process in the pharmaceutical industry.
Facilitate problem-solving and decision making with respect to project deliverables and meeting timelines.
Monitor project budgets to provide updates to the Executive Management Team with needed.
Provide input on project team member performance to aid the functional heads in employee performance evaluations.
Fully understand business cases including all internal and external factors which may derail the project and alert senior management of any potential pitfalls.
Communicate all pre-defined events to team members and other stakeholders according to communication plan. Monitor and communicate any changes in project scope, timeline and cost to all appropriate individuals.
- Bachelors Degree in Business or Science, MS or MBA preferred.
- 3 years project management experience in pharmaceutical environment.
- Exceptional influencing and team development skills.
- Superior organizational skills, must be able to manage multiple projects with high priority.
- Effective communication skills, both verbal and written.
- Solid presentation skills.
- Proficient in Project Management Software.
CLINICAL REGULATORY ASSOCIATE (Norristown, PA)
Nature and Scope
The Regulatory Associate provides administrative support to the Clinical Regulatory group. He/She is responsible for the organization and compilation of the regulatory submissions and maintains the regulatory files to ensure that dossiers are easily retrieved for review by the team. He/She works with pharmacovigilance to process and file Pharmacovigilance reports to the FDA in a timely manner.
Organization and retention of controlled documents, tracking changes made to controlled documents, facilitation of controlled approval, and the design and implementation of systems for record management and archival to ensure orderly storage and expedient retrieval of all documentation according to all applicable regulations.
Assist in the compilation of regulatory submissions, assist in the review of Clinical Documents and writing and processing SOP’s.
Establish and develop proper Standard Operational Procedures for Clinical R&D document control system.
Manage the document control system including the preparation and processing of Controlled Documents and editing and release of controlled documents.
Responsible for the creation and assembly of simple and complex documents for regulatory submission using Microsoft WORD, electronic document management system and publishing software.
Ensures proper indexing and archiving of all assigned clinical documents within the electronic document management system.
Prepares documents for publication using document management system, publishing software and Adobe Acrobat tools. Preparation of documents includes formatting, cross-referencing, linking, creating TOCs, generating PDFs, scanning, etc.
Perform the coordination and preparation of internal and external audits and compliance in accordance with the applicable regulatory requirements.
Coordinate and assist with regulatory agency inspections.
Develop and deliver training on relevant procedures.
Assist with the compilation of Regulatory Submissions.
Assist the Manager of Clinical Regulatory Affairs as needed.
Perform Quality Assurance Audits of Vendors and Investigative Sites.
Bachelor Degree Preferred
At least seven (7) years of documentation control experience including experience implementing document control software packages
Experience in pharmaceutical or medical field
CLINICAL RESEARCH ASSOCIATE (Norristown, PA)
Assist with Administration of clinical research projects: recruiting, investigators, collecting investigator documentation, site management, site monitoring, preparing status reports and completing other technical tasks to completion.
Initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human subjects.
Ensure subject safety through diligent monitoring of the site’s compliance with study protocols and the collection of adverse event information
Update, track and maintain study specific trial management tools/system.
Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with study drug handling procedures. Ensure that all adverse events are collected pursuant to GCP.
Report, write narratives and follow-up on reported serious adverse experiences.
Assist with generation and reconciliation of queries to investigation sites to resolve problem data.
Assist and manage project budget and investigator site budget, attend project team meetings, plan and attend investigator meetings, and communicate with clients.
Generate and track drug shipments and storage.
Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.
Bachelor’s degree required. Preferred degree in the Biological / Health Sciences. Pharmaceutical industry experience a plus.
Minimum 1 year experience in Drug Development, Regulatory Affairs, CRA experience a plus. Dialysis, Rheumatology, Oncology, Cardiology, Pediatrics or GI experience preferred
Ability to travel up to 80%, including overnight
Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously. Detail oriented, self-motivated
Proficiency in MS Word, Excel and Outlook. Knowledge of Medical/Regulatory Terminology
DIRECTOR OF PHARMOCOVIGILANCE (Norristown Office)
- Overseeing the proper and timely collection and the timely reporting of Adverse Event information from all sources as required by regulation (clinical trials, literature, direct report, etc.)
- Preparation of all Safety reports (IND Safety Reports, IND / NDA updates, PSUR’s, Annual reports, etc.)
- Development and maintenance of all Pharmacovigilance related SOPs
- Development, Implementation and maintenance of the company safety database (s)
- Prepares and reviews Adverse Event Trending reports
- Prepares and reviews analysis / reports pertaining to Signal detection/surveillance activities at a medical qualitative level
- Provides medical input/expertise for Data Safety Review Board reviews/label evaluations
- Provides medical review/commentary and Risk Assessments related to ADE reports or associated with quality investigations on an individual case-level or aggregate review level.
- Liaises with company legal consultant regarding medical review/commentary for cases of special interest and matters of regulatory interpretation
- Participation in after hours medical coverage for clinical projects, if required
- Assist other Medical Directors with Project Specific Safety Monitoring
- Interaction with FDA and other regulatory authorities as necessary
- Develop and implement Pharmacovigilance programs and risk management plans
OPERATION, MEDICAL AND SCIENTIFIC SUPPORT:
- Provide medical and scientific support to Quality Assurance and Regulatory Affairs with respect to customer complaints, Adverse Event Trending and regulatory agency inquiries.
- Provide medical and scientific support to Professional Services, and Marketing and Sales departments.
- Medical review of documents associated with product sales and marketing
- Review of protocols, case report forms, guidelines, clinical study reports and manuscripts as requested.
- Protocol and/or therapeutic area training for the project team as requested
- Participation in and/or presentation at Investigator Meetings as requested
- Interaction with CROs, consultants, investigators, outside physicians and other medical professionals
- Medical Safety support for Project Management, Data Management, Biometrics and Clinical Writing
- Strategic Planning / Business Development – Assessment of Pharmaceutical Product Development and providing medical/scientific opinion of new ventures
- Oversees completion and revision of work instructions/SOPs pertaining to post marketed processes
- Liaise w/ Shirley groups (QA/RA/Med Affairs (formerly PS)/Customer Svc) for resolution of any PV-related issues
- Participates in Quality Initiatives and any associated deviations as needed
- Tracks case processing metrics for monthly reports to Sr. Mgmt.
- Prepare SAE narratives, and collaborate with CROs for SAE reconciliation.
- Administrative tasks as required by Sr Management and/or Direct Supervisor to maintain smooth functioning of the Division and compliance with Regulation, Guidance and SOPs
- Training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) expertise
QUALIFICATIONS AND REQUIREMENTS:
- US Medical degree with three years experience preferred. Will consider PharmD or foreign medical degree with 5 years experience, or BSN, MSN with ten years experience.
- Pharmaceutical industry experience (Pharmaceutical or CRO) in Pharmacovigilance and Safety Surveillance, knowledge of drug development safety requirements and history of experience working with safety monitors essential
- Working knowledge of FDA reporting regulations as they pertain to human and veterinary drug products and medical devices for both marketed products and products under development
- Excellent oral and written English communication skills
- Significant computer / technology skills. PV Works safety database experience a plus
- Prior management experience as evidence by previous direct reports
- Drug development experience
- Experience as direct medical liaison with FDA
- Ability to prioritize and perform multiple tasks simultaneously
- Ability to make decisions independently and with appropriate input
- Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, Quality Assurance, Sales, Marketing and Professional Services
- Flexibility in adapting to multiple therapeutic areas interchangeably