Manager, Regulatory Compliance (Pharma) -Located at any CAPS location nationwide
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Manager, Regulatory Compliance (Pharma) -Located at any CAPS location nationwide Job Locations US-CA-Irvine | US-PA-Allentown | US-PA-Horsham | US-MA-Woburn | US-CT-Wallingford | US-CA-Santa Fe Springs | US-CA-Fremont | US-NV-Las Vegas | US-GA-Norcross | US-IL-Chicago | US-TX-Houston | ...
# of Openings:
8am - 5pm
**MEMBERS ONLY**SIGN UP NOW***.®) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.
State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder. CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States. Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.
CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry. We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.
The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs. CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.
Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures. CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff. Quality Assurance reports are provided to our clients on a quarterly basis.
Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests. CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options. Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.
CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered. CAPS has a variety of delivery options including same day and next day services.
Provide quality and regulatory compliance expertise for quality systems and product quality for pharmaceutical compounding processes and related compounded sterile preparations (CSPs) within CAPS. Oversee internal site compliance to applicable regulations, standards and quality systems and through direct interactions across all functional lines and periodic auditing. Establish guidelines and requirements for quality and regulatory compliance in supporting special projects and ongoing operations.
Responsibilities: Essential Duties
Serves as a quality and regulatory compliance expert to the CAPS Operations. Maintains comprehensive knowledge of applicable quality and regulatory requirements and their interpretation.
Assist in the development and support of the company audit program (internal, supplier, customer and regulatory) to ensure timely and effective corrective/preventative actions are developed, implemented and verified to resolve audit observations, while maintaining compliance with applicable FDA Quality System Regulations, USP Regulations, industry standards and meeting/exceeding current industry practices. Serve as the key leader within CAPS to establish, implement and maintain audit readiness program.
Develop, review and verify responses to regulatory agency findings or internal and/or customer observations.
Support Operations to develop requirements for external supplier qualification and ongoing assessments for the manufacturing, laboratories and services areas.
Provide guidance and regulatory advice during the development, implementation and effectiveness verification of the corrective/preventive actions according to the established procedures and established action plans.
Host/support external audits, compliance inquiries and/or surveys.
Develop, track, trend and report to management on compliance metrics. Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action.
Participate in the development and execution of quality/regulatory-related training and education.
Provide support in collaboration with Pharmacy and Quality Operations for the investigation and root cause analysis of product, process and quality systems gaps, deviations and discrepancies.
Provide support for product impact assessments when gaps, deviations and non-conformances in product, processes and quality systems are identified; and provide recommendation of appropriate actions
Work interactively with cross-functional teams to achieve company business and quality goals/objectives.
Stay abreast of evolving regulatory and industry standards trends that are relevant, and ensure that appropriate action is initiated and communicate these trends to applicable personnel.
Ensure compliance to applicable regulations and standards
Responsible to hire, develop, promote and discipline regulatory compliance personnel.
Expertise: Knowledge & Skill Requirements
Good working knowledge of Pharmaceutical (USP , 21 CFR 210 & 211, and 503B, and USP ) and Medical Device (21 CFR 820) Quality System Regulations
Good working knowledge of USP, FDA, ISO and ICH requirements
Excellent computer and PC skills including experience with MS Office applications, database and statistical applications
Sufficient human relations and leadership skills to effectively staff and manage relevant personnel, including external consultants, and functions to assure that company goals and responsibilities are met.
Ability to act effectively as a member of a team to resolve problems.
Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
Ability to investigate and analyze technical and regulatory issues.
Excellent oral and written skills.
Strong interpersonal skills.
Valid driver license and current passport required
Able to travel ≥ 25% per calendar year
Expertise: Qualifications -
BS degree in technical or scientific discipline and eight or more years of related experience preferably in the pharmaceutical or medical device industry.
Experience in auditing for performing and hosting internal audits, supplier audits, 3 rd party audits, Board of Pharmacy/FDA/ISO regulatory inspections.
Experience with USP, cGMP's, and FDA guidelines.
5 or more years Management experience
Certified Quality Auditor (CQA) Preferred
Experience with State Board of Pharmacy
MS or PhD in a related science
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at ****Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.