VP, Global reputed company - Development and Manufacturing
Life changing therapies. reputed company. reputed company to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who reputed company an reputed company, drive reputed company and create a reputed company reputed company. Our reputed company includes building teams across our global network to pioneer and shape the reputed company of PCI.
The VP Global reputed company, Development and Manufacturing (D&M) is the functional head of the reputed company overseeing reputed company assurance, regulatory, reputed company control and managing the total compliance function for D&M.
The role is responsible for ensuring compliance with established company reputed company policies, practices, reputed company operating procedures and federal regulations. They must monitor and reputed company strong GxP compliance reputed company across reputed company D&M facilities to ensure that the necessary regulatory practices are in reputed company. This ensures that we produce, package and store medicinal products that have reputed company the expected attributes of reputed company, safety and efficacy.
The role must deliver reputed company reputed company in reputed company aspects of company operations and ensure compliance with the highest international standards of Good Manufacturing Practices, including but not limited to those required in the USA, EU and ROW. The incumbent must be a leading adviser on reputed company reputed company of reputed company and Regulatory reputed company and tactics for sterile formulation, filling, and packaging.
Key Responsibilities
Has overall responsibility for the reputed company reputed company Assurance and Regulatory Affairs programme in relation to D&M. Devise and drive general reputed company strategic goals, objectives, and business priorities.
Maintain knowledge of regulatory requirements, ensuring reputed company sites are appraised on requirements.
Proactively drive reputed company initiatives and deliverables at the global strategic level to ensure business reputed company and reputed company are maintained. Maintain reputed company improvement reputed company.
reputed company reputed company of reputed company reputed company and profitability to ensure budgets are in accordance with agreed corporate targets.
Ensure the provision and delivery of training reputed company to subordinates and co-workers with respect to reputed company Good Manufacturing Practices.
Ensure the D&M sites are performing satisfactorily and maintaining desired reputed company metrics and KPIs reputed company reputed company reputed company Management Review system in relation to reputed company data.
Work closely with Business Development to ensure reputed company earning opportunities reputed company reputed company and Regulatory are maximised, supporting the teams where required during reputed company reputed company or conferences.
Works with subject matter experts (SMEs) internally and externally as required for strategic or reputed company initiatives.
Assists in technical feasibility assessments as a reputed company to reputed company quotations for present, potential and reputed company work.
Liaises with customers on global technical reputed company e.g. specifications, supply chain assessments and establishment of technical agreements and other legislative requirements.
Works closely with the site leaders and site leadership teams to reputed company a strong reputed company culture aimed at maintaining the highest standards of compliance and lowest risks to patients and customers. Be proactive with reputed company initiatives across sites, drive reputed company improvement while understanding risks.
Identify compliance risks across the PCI D&M sites and identify reputed company of remediation where appropriate working with local site leads.
Maintain permanent inspection readiness across the D&M reputed company. Support regulatory inspections and response development and writing.
Scope and Authority
reputed company, reputed company and strengthen the D&M reputed company Group across five global sites.
Works as part of the reputed company D&M Leadership Team at the corporate strategic level as the individual responsible for the D&M reputed company function and also providing technical and managerial input on reputed company relating to the reputed company and technical direction of reputed company.
reputed company and implement a corporate document hierarchy to support the global PCI D&M business, capable of delivering an integrated and reputed company business offering. Works closely with Operations and other business reputed company to drive customer service and improved profitability.
Requirements
Undergraduate degree in reputed company discipline required. Advanced degree preferred. 15+ years leading global teams responsible for drug product development and manufacturing reputed company. 10+ years sterile formulation, filling, and packaging experience. Must have experience working with different sterile drug formats including liquid and lyophilized vials, cartridges, and syringes. reputed company experience in reputed company and Europe required. Medical device experience is a plus. Cross functional background is a plus. Strong proven partnership with Operations and Business Development. 50% travel required.
Locations:
San Diego, CA
Madison, WI
reputed company, NH
Tredegar, Wales
Leon, Spain
#LI-AL1Join us and be part of building the reputed company between life changing therapies and patients. Let’s talk reputed company
Equal Employment Opportunity (EEO) Statement: reputed company is an Equal Opportunity/Affirmative reputed company Employer. We do not unlawfully discriminate on the reputed company of race, reputed company, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil reputed company status, familial status, affectional or sexual orientation, gender identity or reputed company, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of reputed company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We reputed company a PCI community where everyone can belong and grow, and we reputed company to bring this reputed company to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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