External Manufacturing Job Description
External manufacturing
provides visibility to the business on new Health Authority regulations or changing expectations and results of Health Authority inspections.
External Manufacturing Duties & Responsibilities
To write an effective external manufacturing job description, begin by listing detailed duties, responsibilities and expectations. We have included external manufacturing job description templates that you can modify and use.
Sample responsibilities for this position include:
Influence suppliers’ strategic direction to align to Shire corporate goals/vision providing
Change owner for manufacturing vendor change notifications
Establish and maintain detailed project plans
Leads all aspects of co-manufacturing operations
Identify and implement effective process control systems at the supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Complete Non-conformances, CAPAs, Change Management and Batch Release related to suppliers within required timelines
Provide technical mentorship and resolve quality supply chain issues with the company's suppliers
Provide effective leadership in supporting quality disciplines, decisions, and practices across North America region
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating,and resolving quality issues with suppliers
Assist QA functions, supply chain and R&D organizations in sourcing new suppliers
External Manufacturing Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for External Manufacturing
List any licenses or certifications required by the position: PMP, CPIM, CSCP, ASQ, CPSM, APICS, EM, CPM, CIPS, ISM
Education for External Manufacturing
Typically a job would require a certain level of education.
Employers hiring for the external manufacturing job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Business, Chemistry, Technical, Manufacturing, MBA, Life Sciences, Pharmacy, Business/Administration
Skills for External Manufacturing
Desired skills for external manufacturing include:
Familiarity with ICH guidelines and EU regulations
FDA regulations
Industry practices and regulations
Regulatory compliance inclusive of cGMP
SAP
Advanced Planning systems is desired
Global GMP and regulatory requirements
MRP
Health authority regulations
Drug product manufacturing from formulation through the final package
Desired experience for external manufacturing includes:
Supply chain operations experience in multiple functional areas such as Planning, Procurement, Capital Engineering and Manufacturing
Experience interpreting and implementing technical changes (ie process, equipment, ) in a manufacturing environment
Assist Quality Assurance functions, supply chain and R&D organizations in sourcing new suppliers
6+ years within a Supplier Quality organization, with at least 4 years of experience in the Medical Device or Pharmaceutical industry
Master's Degree in an Engineering or Technical related discipline
Familiar with 21 CFR Part 820, ISO 13485, JSO 14971,Council Directive 93/42/EEC (Medical Devices Directive) and FDA 210/211
External Manufacturing Examples
1
External Manufacturing Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of external manufacturing. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for external manufacturing
- Assist EM QA functions, supply chain and R&D organizations in systematic problem-solving methodologies
- Assist quality management in all audits
- Identify and implement effective process control systems at the EM supplier sites
- Provide technical mentorship and resolve quality supply chain issues
- Managing all aspects of the manufacturing operations to ensure appropriate level of customer service cost and compliance
- Driving performance in terms of EHSS & Quality Compliance and other applicable J&J policies
- Driving implementation of continuous improvement initiatives including but not limited to lean, M2W, SQE2, including identification, business case justification and execution
- Ensure project execution at site level (NPD, Product transfers, CIPs, roll outs, new equipment specification definition and installation...)
- Ensure Account Plans are set, aligned with key stakeholders and executed
- Participate on Risk Assessment activities and be accountable for the operational elements for external sites
Qualifications for external manufacturing
- Ensure proper service Level Agreements are set, included in the contracts and adhere to standards
- Coordinate / support NPI/ roll outs/ reformulations/ packaging & artworks changes/ technical transfers at EM sites and deliver against established timelines, forecasted volumes and costs
- Coordinate and implement Quality & Compliance improvement initiatives with EMs in partnership with the Q&C team
- Coordinate / lead efficient implementation of new EM sites and exits, in the case of site rationalization
- Control budget and manage spending of non-standard costs from projects and change controls with EMs
- Be responsible for ensuring quality and supply continuity of externally manufactured products for various Ethicon EMs
2
External Manufacturing Job Description
Job Description Example
Our growing company is looking for an external manufacturing. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for external manufacturing
- Complete failure investigations for customer complaints
- Initiate and lead cost improvement projects and partnering with Ethicon franchise resources in R&D and FOD-PM (franchise operations development –Product Management) to receive new products launched at external production sites
- Focus on various Electro-mechanical engineer competencies and their related manufacturing processes, but could also range across other technologies, materials, and process, as business needs dictate
- Cover Capital, reusable, and disposable product variations
- Act as sustaining engineer for our externally manufactured products and will manage projects and lead or participate in cross functional teams to address supply continuity, quality & compliance and cost management challenges
- Ensure the team has what they need in terms of technical information to make decisions
- Be a technical leader and change agent, who communicates objectives, sets the tone, establishes a positive climate, and creates a forum for buy-in
- Define and manage requirements/ boundaries for intellectual property or trade secrets when working with external partners
- Use sound judgment when committing resources and time through the understanding of business risks and benefits, in order to improve value to customers and to the Organization
- Recognize when to lead and when to ask for direction
Qualifications for external manufacturing
- Maintain clear communication with internal and external business partners regarding expectations, satisfaction, or quality of results
- Have a strong working knowledge of various materials (Electronics / PCBA plastic and metal) and manufacturing processes general engineering skills
- Represents EM-MAKE in Area Cluster Leadership Team
- Demonstrated knowledge and experience with Instructional Design needs assessment, design, practices, and processes for manufacturing, professional and leader audiences
- Demonstrated experience producing training plans and materials for instruction
- Demonstrated experience delivering innovative learning solutions
3
External Manufacturing Job Description
Job Description Example
Our company is growing rapidly and is looking for an external manufacturing. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for external manufacturing
- Create and maintain data in SAP system in accordance with departmental procedures
- Responsible for SAP inventory transactions to ensure NLT 98% accuracy of all Emergent purchased materials located at External Manufacturers
- Proactively identify and escalate risks and issues to relevant stakeholders
- Drive goals against business imperatives by leading and participating on cross-functional teams
- Be a leader and key influencer within the North America Consumer SC Procurement team
- Opportunity to manage interns, contractors and/or co-ops
- Ensure that 3rd-party organizations manufacturing, packaging, controlling and handling J&J products fully understand and meet J&J Consumer quality and compliance expectations
- New Product (approx
- Develop identified External Manufacturers through identification of their needs and implementation of continuous improvement initiatives in the scope and in alignment with the defined Sourcing Strategies
- Data Management (approx
Qualifications for external manufacturing
- Ability to effectively analyze trends, forecast spend
- Minimum of 12 years of manufacturing and professional experience in curriculum design/development, and learning/leadership development
- Ideally 2+ years experience in the pharmaceutical industry in a Technical Operations or Development function
- Strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required
- Analytical mindset and strong process orientation
- Strong organizational and coordination skills, ability to keep high level overview
4
External Manufacturing Job Description
Job Description Example
Our company is hiring for an external manufacturing. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for external manufacturing
- Support Contract Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reviewing Annual Drug Product Review reports, reporting Contract Manufacturer performance metrics, interfacing with J&J business partners and providing batch release when required
- Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues
- At times, represent Quality Assurance on project and improvement teams by guiding setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support
- Act as the Subject Matter Expert (SME) for quality assurance processes, procedures, and activities
- Provide detailed or summary communication to senior cross-functional leadership on the status of key initiatives
- Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses
- Design/implement quality and compliance improvement programs and initiatives
- Represent North America Source Quality on multiple, simultaneous, high-impact/ high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring quality and compliance inputs are integrated into the project objectives, and act as a QA “go-to” resource for cross-functional business partners
- Review and approve compliance records, specifications, new product introduction development plans, procedures, and other documents, as required by procedure
- Drive External Manufacturing alignment to Micron Quality Systems and requirements
Qualifications for external manufacturing
- Undergraduate degree in Engineering or related science required, Master’s degree and/or PhD desired
- Overall strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations
- Experience working with third parties such as CMOs, Contract Labs and partners
- Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices
- In depth understanding of technology processes including API manufacturing, packaging technologies desired
- Understanding of technology, regulatory and quality requirements, validation approaches, key risk areas and industry trends
5
External Manufacturing Job Description
Job Description Example
Our company is growing rapidly and is looking for an external manufacturing. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for external manufacturing
- Drive problem resolution, identify root cause, containment, corrective and preventive actions
- Coordinate and participate in External Manufacturing Audits
- Coordinate response for Customer Request
- Manage External Manufacturing Change Control
- Drive External Manufacturing Sub-tier Supplier Quality Management
- Reporting of Weekly / Monthly Quality Metrics
- Support distribution and logistics transactional and planning activities to meet customer requirements
- Collaborates with the external partner to ensure that effective and robust Quality Systems and Quality management are in place
- Is responsible for defining Quality expectations on Process Change Requests (PCRs) submitted by the external partner and ensuring conformance to all PCR requirements prior to authorizing release of batches made under the changes
- Ensure CM’s deliver on new product launch start of ship requirements by managing both the C&D/CM communication process the CM’s internal processes (master data creation, material ordering, capacity planning, etc…)
Qualifications for external manufacturing
- 5 years relevant experience in contract manufacturing desired
- Demonstrated interpersonal skills to develop effective working relationships with internal stakeholders, CMOs, and cross-functional, cross-cultural project teams
- Ability to partner with External Quality to ensure CMO compliance to Intarcia quality standards, cGMP's and other international quality standards and regulations
- Ability to lead effective cross-functional team performance to deliver per our supply chain needs and requirements
- Demonstrated leadership and project management skills to effectively and independently plan, manage, and lead large technical programs, personnel, and cross-functional, multi-cultural, cross- enterprise project teams
- Experience in developing and implementing processes, systems, and standards used for establishing and managing contract manufacturing relationships